Regulatory aspects of QUM in India: Regulation of complementary medicines, Regulation of OTC medicines.

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QUM regulation complementary medicines OTC India CDSCO regulatory framework

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Regulatory Aspects of QUM in India: Complementary Medicines & OTC Medicines

Quality Use of Medicines (QUM) in India is governed by a layered framework involving central legislation, regulatory bodies, and system-specific authorities. Two areas with distinct (and evolving) regulatory landscapes are complementary medicines and over-the-counter (OTC) medicines.

1. Regulation of Complementary Medicines in India

What Are Complementary Medicines?

Complementary medicines (CMs) include traditional, herbal, and alternative health products used alongside or instead of conventional medicine. In India, these are primarily the AYUSH systems - Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy.

Legislative Framework

The primary legislation governing complementary medicines in India includes:

Legislation	Scope
Drugs and Cosmetics Act, 1940 (amended 2009)	Regulates manufacture, import, distribution, and sale of Ayurvedic, Siddha, and Unani (ASU) drugs - specifically under Chapter IVA
Drugs and Cosmetics Rules, 1945	Operational rules; Schedule T covers GMP for ASU drugs; Schedule M-I defines standards
Indian Medicines Central Council Act, 1970	Regulates education and practice of practitioners of Indian medicine
Homeopathy Central Council Act, 1973	Regulates homeopathy education and practice
Drugs (Control) Act, 1950	Supplementary control on drug supply

The Drugs and Cosmetics Act contains key provisions relevant to QUM:

Section 33EEB: Regulation of manufacture for sale of ASU drugs - manufacturing must be under technically qualified personnel (a degree holder in Ayurveda, Siddha, Unani, or Ayurvedic Pharmacy)
Section 33EEC: Prohibition of manufacture/sale of certain ASU drugs (misbranded, adulterated, spurious)
Section 33EED: Central Government power to prohibit manufacture of any ASU drug that lacks claimed therapeutic value
Section 33E / 33EE / 33EEA: Definitions of misbranded, adulterated, and spurious ASU drugs respectively

Regulatory Authority: Ministry of AYUSH

The Department of Indian Systems of Medicine and Homeopathy was created in 1995 and later renamed as the Department of AYUSH. It was elevated to a full Ministry of AYUSH in 2014 under the Ministry of Health and Family Welfare (MoHFW).

Key functions:

Serves as the national office for traditional and complementary medicine (T&CM)
Formulates policy, standards, and quality guidelines for AYUSH drugs
Oversees pharmacopoeia development and pharmacovigilance

India also has a National Policy on Indian Systems of Medicine and Homeopathy (2002), which provides the strategic direction for integrating T&CM into national healthcare.

Quality Control Mechanisms for AYUSH Drugs

1. Pharmacopoeia Standards

The Ayurvedic Pharmacopoeia of India (API) and National Formulary of Ayurvedic Medicine (NFAM)
The Unani Pharmacopoeia of India (UPI) and National Formulary of Unani Medicine
The Siddha Pharmacopoeia of India These set official standards for identity, purity, and quality of raw materials and formulations.

2. Good Manufacturing Practice (GMP)

Schedule M-I of the Drugs & Cosmetics Rules, 1945 specifies GMP requirements for ASU drug manufacturing units
As of recent data, over 8,369 licensed ASU&H drug manufacturing units are registered with Ministry of AYUSH
27-29 State Drug Testing Laboratories (SDTLs) support quality testing
81 laboratories are approved under Drugs and Cosmetics Rules, 1945 for quality testing of ASU drugs and raw materials

3. Certification Schemes

WHO Certification of Pharmaceutical Products (CoPP) for herbal products
AYUSH Premium Mark - granted by the Quality Council of India (QCI) through third-party evaluation
Collaboration with Bureau of Indian Standards (BIS) and QCI for accreditation/certification

4. Pharmacovigilance

Pharmacovigilance Centers for ASU&H drugs are established across India under a Central Scheme of the Ministry of AYUSH
These centers monitor adverse events AND report misleading advertisements to State Regulatory Authorities
Surveillance of misleading advertising is a core QUM function under the National AYUSH Mission (NAM)

5. Capacity Building under National AYUSH Mission (2014-2021)

Strengthening State Government AYUSH pharmacies
Up-gradation of drug testing laboratories
Strengthening Central and State regulatory frameworks
Human resource capacity building in quality control and standardization

Global Context and WHO Alignment

India's AYUSH framework aligns with the WHO Traditional Medicine Strategy 2025-2034, which advocates for rigorous evidence, quality standards, and equitable implementation. As of 2018, ~65% of WHO member states (125 countries) had a registration system for herbal medicines; herbal medicines are sold as OTC or self-medication drugs in 79 countries and as prescription medicines in 60 countries. Globally, 34 countries include herbal medicines on their essential medicines list.

Key Gaps and Challenges

The number of dedicated AYUSH drug inspectors remains limited relative to the volume of manufacturing units
Evidence generation for safety and efficacy of traditional formulations remains inconsistent
Overlap between CDSCO and Ministry of AYUSH jurisdictions can create regulatory uncertainty for combination products

2. Regulation of OTC Medicines in India

Current Status: A Regulatory Gap

One of the most significant QUM challenges in India is that there is currently no separate, formally defined category for OTC medicines under Indian law. This is in sharp contrast to most developed nations, where OTC medicines have dedicated regulatory pathways.

As the PMC review (2023) states:

"In India, till date, there are no guidelines for licensing OTC medicines. There is no separate category allotted for OTC medicines in India, and the drugs that do not come under the prescription medicines schedule are generally sold as over-the-counter medicines."

How OTC Medicines Are Currently Identified

Under the existing framework, a drug is considered "OTC" by exclusion - if it does not appear on a prescription-only schedule, it can generally be sold without a prescription.

Key Schedules Relevant to OTC Status:

Schedule	Description	OTC Relevance
Schedule H	Prescription-only drugs (antibiotics, antivirals, etc.)	NOT OTC
Schedule H1	Restricted antibiotics and anti-TB drugs (stricter controls)	NOT OTC
Schedule X	Narcotic and psychotropic substances	NOT OTC
Schedule G	Drugs to be used under medical supervision (must carry warning)	NOT OTC
Schedule K	Drugs exempt from certain licensing provisions; some household remedies	Potential OTC candidates

Schedule K is the closest India has to an OTC list. It includes common household remedies such as:

Paracetamol
Eucalyptus oil
Liquid paraffin
Tinctures
Some cough and cold formulations

Schedule K also allows certain medicines to be dispensed by non-chemists / non-drug licensed stores in areas with populations below 1,000 - a pragmatic rural access provision.

Distribution and Access

Unlike many countries, India does not currently allow the sale of OTC drugs from non-pharmacy outlets such as supermarkets, convenience stores, or petrol stations. However, pharmaceutical companies have begun targeting post offices as points of sale, particularly to reach rural populations - a model that could broaden OTC access economically.

The Push for a Formal OTC Framework

Ahooja Committee Recommendations A formal OTC drug category was outlined based on recommendations of the Ahooja Committee, later approved by the Drugs Consultative Committee (DCC). The recommended framework covered:

Define and prepare an initial list of OTC drugs
Regulate the Rx-to-OTC switch process
Regulate new OTC drug approvals
Regulate distribution and sale of OTC drugs
Regulate advertising of OTC drugs

Draft Rules by MoHFW The Ministry of Health and Family Welfare (MoHFW) put out draft rules that, for the first time, formally identified 16 drugs as OTC candidates, including antifungals and other commonly self-used products. The term "OTC" was recommended as a distinct category in Indian drug law.

Rx-to-OTC Switch India currently lacks a well-documented formal process for switching prescription (Rx) drugs to OTC status. The Indian regulatory authority (CDSCO) is expected to define and prepare an official OTC drug list based on criteria including:

Extent of evidence for safety
Therapeutic index (wide margin of safety)
Need for patient accessibility
Non-habit-forming nature
Present supply-chain mechanism
Socio-economic conditions of the country

Advertising and Promotion Controls

India's regulatory framework does permit advertising of selected OTC products, which serves dual purposes:

Increasing disease awareness among consumers
Broadening access to OTC products across the population

This is an element of QUM because well-regulated advertising can support appropriate self-care; poorly regulated advertising drives irrational use.

Risks of the Current Unregulated OTC Environment

The absence of a formal OTC framework creates the following QUM concerns:

Excessive dosage and polypharmacy through self-medication
Drug interactions without pharmacist oversight
Drug abuse (particularly with OTC antihistamines, analgesics, cough suppressants)
Inappropriate use in special populations - pediatric, geriatric, pregnant, renally impaired patients
Spurious and substandard products entering the supply chain

Comparison: India vs. Global OTC Frameworks

Feature	India (Current)	Most Developed Countries
Defined OTC category in law	No (being developed)	Yes
Rx-to-OTC switch pathway	Absent/informal	Formal, evidence-based
Sale in non-pharmacy outlets	Restricted (pharmacy/licensed only)	Permitted for many products
Advertising regulation	Partial	Comprehensive
OTC labeling requirements	No specific OTC label standard	Mandatory patient information

Summary

Area	Key Regulatory Body	Primary Legislation	QUM Status
Complementary/AYUSH medicines	Ministry of AYUSH	D&C Act 1940 (Chapter IVA), Indian Medicines Central Council Act 1970	Structured but workforce-limited; pharmacovigilance established
OTC medicines	CDSCO / MoHFW	D&C Act 1940 (Schedule H, K, G, X)	No formal OTC category yet; draft rules pending; largely exclusion-based

India's regulatory landscape for both complementary and OTC medicines is evolving. For complementary medicines, the AYUSH framework provides a reasonably structured (if under-resourced) quality control system. For OTC medicines, India is in a transitional phase - the existing framework relies on schedule exclusions rather than affirmative OTC licensing, and formal rules are anticipated in the near future to align with QUM principles of appropriate, safe self-medication.

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ls -la /tmp/workspace/ 2>/dev/null || echo "workspace not found"

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mkdir -p /tmp/workspace/qum-india-ppt

Writing File

~/qum-india-ppt/create_ppt.py

from pptx import Presentation
from pptx.util import Inches, Pt, Emu
from pptx.dml.color import RGBColor
from pptx.enum.text import PP_ALIGN, MSO_ANCHOR
from pptx.enum.shapes import MSO_SHAPE
from io import BytesIO

# ── Colour palette ──────────────────────────────────────────────────────────
DEEP_BLUE    = RGBColor(0x1A, 0x3A, 0x5C)   # dark navy
MID_BLUE     = RGBColor(0x1E, 0x6E, 0xB5)   # medium blue
ACCENT_GREEN = RGBColor(0x27, 0xAE, 0x60)   # green accent
ACCENT_ORG   = RGBColor(0xE6, 0x7E, 0x22)   # orange accent
LIGHT_BG     = RGBColor(0xF0, 0xF4, 0xF9)   # very light blue-grey
WHITE        = RGBColor(0xFF, 0xFF, 0xFF)
DARK_TEXT    = RGBColor(0x1A, 0x1A, 0x2E)
GREY_TEXT    = RGBColor(0x55, 0x55, 0x55)
LIGHT_RULE   = RGBColor(0xC5, 0xD8, 0xEE)
TEAL         = RGBColor(0x0E, 0x8A, 0x8A)

W = Inches(13.333)
H = Inches(7.5)

prs = Presentation()
prs.slide_width  = W
prs.slide_height = H
blank = prs.slide_layouts[6]

# ── Helper functions ─────────────────────────────────────────────────────────

def add_rect(slide, x, y, w, h, fill_rgb, alpha=None, line_rgb=None, line_width=Pt(0)):
    shp = slide.shapes.add_shape(MSO_SHAPE.RECTANGLE, x, y, w, h)
    shp.fill.solid()
    shp.fill.fore_color.rgb = fill_rgb
    if line_rgb:
        shp.line.color.rgb = line_rgb
        shp.line.width = line_width
    else:
        shp.line.fill.background()
    shp.shadow.inherit = False
    return shp

def add_text(slide, txt, x, y, w, h, size=Pt(16), bold=False, color=DARK_TEXT,
             align=PP_ALIGN.LEFT, italic=False, font="Calibri"):
    tb = slide.shapes.add_textbox(x, y, w, h)
    tf = tb.text_frame
    tf.word_wrap = True
    tf.margin_left = 0; tf.margin_right = 0
    tf.margin_top = 0;  tf.margin_bottom = 0
    p  = tf.paragraphs[0]
    p.alignment = align
    r  = p.add_run()
    r.text = txt
    r.font.name  = font
    r.font.size  = size
    r.font.bold  = bold
    r.font.italic = italic
    r.font.color.rgb = color
    return tb

def add_multiline(slide, lines, x, y, w, h, size=Pt(15), bold=False, color=DARK_TEXT,
                  align=PP_ALIGN.LEFT, line_space=Pt(4), font="Calibri"):
    """lines: list of (text, bold_override, color_override, indent_level)"""
    tb = slide.shapes.add_textbox(x, y, w, h)
    tf = tb.text_frame
    tf.word_wrap = True
    tf.margin_left  = Inches(0.05)
    tf.margin_right = 0
    tf.margin_top   = 0
    tf.margin_bottom = 0
    first = True
    for item in lines:
        if isinstance(item, str):
            txt, b, c, lvl = item, bold, color, 0
        else:
            txt = item[0]
            b   = item[1] if len(item) > 1 else bold
            c   = item[2] if len(item) > 2 else color
            lvl = item[3] if len(item) > 3 else 0
        if first:
            p = tf.paragraphs[0]; first = False
        else:
            p = tf.add_paragraph()
        p.alignment = align
        p.level = lvl
        if line_space:
            from pptx.util import Pt as _Pt
            from pptx.oxml.ns import qn
            from lxml import etree
            pPr = p._pPr if p._pPr is not None else p._p.get_or_add_pPr()
            spc = etree.SubElement(pPr, qn('a:spcBef'))
            spcPts = etree.SubElement(spc, qn('a:spcPts'))
            spcPts.set('val', str(int(line_space.pt * 100)))
        r = p.add_run()
        r.text = txt
        r.font.name  = font
        r.font.size  = size
        r.font.bold  = b
        r.font.color.rgb = c
    return tb

def slide_header(slide, title, subtitle=None):
    """Dark navy top bar with title."""
    add_rect(slide, 0, 0, W, Inches(1.15), DEEP_BLUE)
    add_text(slide, title, Inches(0.45), Inches(0.12), Inches(12), Inches(0.85),
             size=Pt(30), bold=True, color=WHITE, align=PP_ALIGN.LEFT)
    if subtitle:
        add_text(slide, subtitle, Inches(0.45), Inches(0.88), Inches(11), Inches(0.3),
                 size=Pt(13), bold=False, color=LIGHT_RULE, align=PP_ALIGN.LEFT)
    # bottom accent stripe
    add_rect(slide, 0, Inches(1.15), W, Inches(0.06), MID_BLUE)

def slide_footer(slide, txt="QUM in India | Regulatory Aspects"):
    add_rect(slide, 0, Inches(7.15), W, Inches(0.35), DEEP_BLUE)
    add_text(slide, txt, Inches(0.3), Inches(7.17), Inches(10), Inches(0.28),
             size=Pt(10), color=LIGHT_RULE, align=PP_ALIGN.LEFT)

def slide_bg(slide):
    add_rect(slide, 0, 0, W, H, LIGHT_BG)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 1 — Title slide
# ═══════════════════════════════════════════════════════════════════════════
s1 = prs.slides.add_slide(blank)
# Full bg gradient emulated with 2 rects
add_rect(s1, 0, 0, W, H, DEEP_BLUE)
add_rect(s1, 0, Inches(4.5), W, Inches(3), MID_BLUE)

# Decorative shapes
shp = s1.shapes.add_shape(MSO_SHAPE.OVAL, Inches(10.5), Inches(-1), Inches(4), Inches(4))
shp.fill.solid(); shp.fill.fore_color.rgb = RGBColor(0x1E, 0x5A, 0x8A)
shp.line.fill.background(); shp.shadow.inherit = False

shp2 = s1.shapes.add_shape(MSO_SHAPE.OVAL, Inches(-1), Inches(5.5), Inches(3), Inches(3))
shp2.fill.solid(); shp2.fill.fore_color.rgb = RGBColor(0x0A, 0x2A, 0x4A)
shp2.line.fill.background(); shp2.shadow.inherit = False

# Green accent bar
add_rect(s1, Inches(0.5), Inches(2.8), Inches(0.1), Inches(2), ACCENT_GREEN)

add_text(s1, "Regulatory Aspects of QUM in India",
         Inches(0.8), Inches(1.6), Inches(11.5), Inches(1.4),
         size=Pt(40), bold=True, color=WHITE, align=PP_ALIGN.LEFT)

add_text(s1, "Quality Use of Medicines",
         Inches(0.8), Inches(3.0), Inches(10), Inches(0.6),
         size=Pt(22), bold=False, color=LIGHT_RULE, align=PP_ALIGN.LEFT)

add_multiline(s1, [
    ("Regulation of Complementary Medicines", True, ACCENT_GREEN, 0),
    ("Regulation of OTC Medicines", True, ACCENT_ORG, 0),
], Inches(0.8), Inches(3.7), Inches(10), Inches(1.2), size=Pt(20))

add_text(s1, "Ministry of AYUSH  |  CDSCO  |  Drugs & Cosmetics Act, 1940",
         Inches(0.8), Inches(5.5), Inches(11), Inches(0.5),
         size=Pt(13), color=LIGHT_RULE, align=PP_ALIGN.LEFT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 2 — Agenda
# ═══════════════════════════════════════════════════════════════════════════
s2 = prs.slides.add_slide(blank)
slide_bg(s2)
slide_header(s2, "Agenda")
slide_footer(s2)

agenda = [
    (ACCENT_GREEN, "1", "Complementary Medicines — Introduction & Definition"),
    (ACCENT_GREEN, "2", "WHO Strategy for Traditional & Complementary Medicine"),
    (ACCENT_GREEN, "3", "Legislative Framework for AYUSH in India"),
    (ACCENT_GREEN, "4", "Quality Control Mechanisms for AYUSH Drugs"),
    (ACCENT_ORG,   "5", "OTC Medicines — Current Regulatory Status"),
    (ACCENT_ORG,   "6", "Key Schedules: H, G, K, X"),
    (ACCENT_ORG,   "7", "Push for a Formal OTC Framework"),
    (ACCENT_ORG,   "8", "Risks of Unregulated OTC Environment"),
    (MID_BLUE,     "9", "India vs Global OTC Comparison & Way Forward"),
]

for i, (col, num, text) in enumerate(agenda):
    row_y = Inches(1.35) + i * Inches(0.6)
    add_rect(s2, Inches(0.5), row_y, Inches(0.5), Inches(0.45), col)
    add_text(s2, num, Inches(0.5), row_y, Inches(0.5), Inches(0.45),
             size=Pt(16), bold=True, color=WHITE, align=PP_ALIGN.CENTER)
    add_text(s2, text, Inches(1.1), row_y + Inches(0.04), Inches(11), Inches(0.4),
             size=Pt(16), color=DARK_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 3 — CAM: Introduction
# ═══════════════════════════════════════════════════════════════════════════
s3 = prs.slides.add_slide(blank)
slide_bg(s3)
slide_header(s3, "Complementary Medicines — Introduction", "Definition & Classification")
slide_footer(s3)

# Left card
add_rect(s3, Inches(0.4), Inches(1.35), Inches(5.8), Inches(5.5), WHITE,
         line_rgb=LIGHT_RULE, line_width=Pt(1.2))
add_rect(s3, Inches(0.4), Inches(1.35), Inches(5.8), Inches(0.45), ACCENT_GREEN)
add_text(s3, "Complementary Medicine (CM)",
         Inches(0.55), Inches(1.38), Inches(5.5), Inches(0.4),
         size=Pt(15), bold=True, color=WHITE)
add_multiline(s3, [
    ("Used ALONGSIDE conventional medicine", False, DARK_TEXT, 0),
    ("Goal: enhance or support standard treatment", False, DARK_TEXT, 0),
    ("Examples: Yoga, Ayurveda alongside allopathy", False, DARK_TEXT, 0),
], Inches(0.55), Inches(1.9), Inches(5.5), Inches(1.2), size=Pt(14), line_space=Pt(6))

add_rect(s3, Inches(0.55), Inches(3.3), Inches(5.5), Inches(0.03), LIGHT_RULE)

add_text(s3, "Types of CAM Practices", Inches(0.55), Inches(3.45), Inches(5.5), Inches(0.4),
         size=Pt(14), bold=True, color=MID_BLUE)
cam_types = [
    "Mind-Body Therapies  (Yoga, Meditation, Naturopathy)",
    "Biologically Based Practices  (Herbs, Dietary supplements)",
    "Whole Medical Systems  (Ayurveda, Unani, Siddha, Homeopathy)",
    "Energy Therapies  (Reiki, Magnet therapy)",
    "Manipulative Practices  (Massage, Chiropractic)",
]
add_multiline(s3, [(t, False, DARK_TEXT, 0) for t in cam_types],
              Inches(0.55), Inches(3.9), Inches(5.5), Inches(2.5), size=Pt(13), line_space=Pt(5))

# Right card
add_rect(s3, Inches(6.6), Inches(1.35), Inches(6.3), Inches(5.5), WHITE,
         line_rgb=LIGHT_RULE, line_width=Pt(1.2))
add_rect(s3, Inches(6.6), Inches(1.35), Inches(6.3), Inches(0.45), MID_BLUE)
add_text(s3, "Alternative vs. Complementary",
         Inches(6.75), Inches(1.38), Inches(6.0), Inches(0.4),
         size=Pt(15), bold=True, color=WHITE)

rows = [
    ("Feature",           "Complementary",      "Alternative", True),
    ("Use",               "WITH conventional",  "INSTEAD OF conventional", False),
    ("Integration",       "High",               "Low", False),
    ("Safety oversight",  "Shared with AYUSH",  "Variable", False),
    ("WHO stance",        "Encouraged",         "Caution advised", False),
]
col_x = [Inches(6.75), Inches(8.85), Inches(11.1)]
col_w = [Inches(2.0),  Inches(2.15), Inches(1.7)]
for ri, row in enumerate(rows):
    ry = Inches(2.0) + ri * Inches(0.7)
    bg = LIGHT_BG if ri % 2 == 0 else WHITE
    if ri == 0: bg = DEEP_BLUE
    add_rect(s3, Inches(6.75), ry, Inches(6.0), Inches(0.62), bg)
    for ci, cell in enumerate(row[:3]):
        fc = WHITE if ri == 0 else DARK_TEXT
        add_text(s3, cell, col_x[ci], ry + Inches(0.08), col_w[ci], Inches(0.5),
                 size=Pt(12), bold=(ri == 0), color=fc)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 4 — WHO Strategy
# ═══════════════════════════════════════════════════════════════════════════
s4 = prs.slides.add_slide(blank)
slide_bg(s4)
slide_header(s4, "WHO Strategy for Traditional & Complementary Medicine",
             "WHO TM Strategy 2025–2034")
slide_footer(s4)

add_rect(s4, Inches(0.4), Inches(1.35), Inches(12.5), Inches(0.75), MID_BLUE)
add_text(s4, "WHO defines TCIM as experience-based health systems that can align with national healthcare frameworks when implemented safely and with evidence.",
         Inches(0.6), Inches(1.42), Inches(12.0), Inches(0.6),
         size=Pt(13), italic=True, color=WHITE)

pillars = [
    (ACCENT_GREEN, "1. Build Knowledge Base",
     ["Evidence-based research on T&CM", "Generate clinical trial data", "Establish safety/efficacy standards"]),
    (MID_BLUE, "2. Strengthen Regulation",
     ["National policies on T&CM", "Registration of products & practitioners", "Quality standards & pharmacopoeia"]),
    (ACCENT_ORG, "3. Integrate into Health Systems",
     ["Include T&CM in national health plans", "Train conventional practitioners", "Ensure equitable access"]),
    (TEAL, "4. Promote Rational Use",
     ["Patient information & awareness", "Practitioner competency standards", "Adverse event monitoring (Pharmacovigilance)"]),
]

for i, (col, title, points) in enumerate(pillars):
    cx = Inches(0.4) + i * Inches(3.1)
    add_rect(s4, cx, Inches(2.3), Inches(3.0), Inches(4.5), WHITE,
             line_rgb=col, line_width=Pt(2))
    add_rect(s4, cx, Inches(2.3), Inches(3.0), Inches(0.5), col)
    add_text(s4, title, cx + Inches(0.1), Inches(2.33), Inches(2.8), Inches(0.45),
             size=Pt(13), bold=True, color=WHITE)
    add_multiline(s4, [(p, False, DARK_TEXT, 0) for p in points],
                  cx + Inches(0.15), Inches(2.9), Inches(2.7), Inches(3.7),
                  size=Pt(12), line_space=Pt(8))

add_text(s4, "India's AYUSH framework aligns with WHO TM Strategy 2025–2034",
         Inches(0.4), Inches(6.95), Inches(12), Inches(0.35),
         size=Pt(13), bold=True, color=MID_BLUE, align=PP_ALIGN.CENTER)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 5 — Legislative Framework
# ═══════════════════════════════════════════════════════════════════════════
s5 = prs.slides.add_slide(blank)
slide_bg(s5)
slide_header(s5, "Legislative Framework for AYUSH in India",
             "Governing Laws & Regulatory Bodies")
slide_footer(s5)

laws = [
    (DEEP_BLUE, "Drugs & Cosmetics Act, 1940",
     "Chapter IVA governs ASU drugs. Sec 33EEB–33EED: manufacture regulation, prohibition powers. Amended 2009."),
    (MID_BLUE, "Drugs & Cosmetics Rules, 1945",
     "Schedule T: GMP for ASU drug units. Schedule M-I: quality standards for manufacturing."),
    (ACCENT_GREEN, "Indian Medicines Central Council Act, 1970",
     "Regulates education & practice of Indian medicine practitioners (Ayurveda, Unani, Siddha)."),
    (ACCENT_ORG, "Homeopathy Central Council Act, 1973",
     "Regulates homeopathy education and practice across India."),
    (TEAL, "Drugs (Control) Act, 1950",
     "Supplementary control over drug supply and availability."),
    (RGBColor(0x8E, 0x44, 0xAD), "National Policy on ISM & Homeopathy, 2002",
     "Strategic direction for integrating T&CM into national healthcare; basis for AYUSH formation."),
]

for i, (col, title, desc) in enumerate(laws):
    row = i // 2
    col_n = i % 2
    lx = Inches(0.4) + col_n * Inches(6.4)
    ly = Inches(1.45) + row * Inches(1.85)
    add_rect(s5, lx, ly, Inches(6.1), Inches(1.65), WHITE,
             line_rgb=col, line_width=Pt(2))
    add_rect(s5, lx, ly, Inches(0.18), Inches(1.65), col)
    add_text(s5, title, lx + Inches(0.28), ly + Inches(0.1), Inches(5.7), Inches(0.5),
             size=Pt(14), bold=True, color=col)
    add_text(s5, desc, lx + Inches(0.28), ly + Inches(0.62), Inches(5.65), Inches(0.9),
             size=Pt(12), color=GREY_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 6 — AYUSH Regulatory Authority
# ═══════════════════════════════════════════════════════════════════════════
s6 = prs.slides.add_slide(blank)
slide_bg(s6)
slide_header(s6, "Ministry of AYUSH — Regulatory Authority",
             "Structure, Timeline & Key Functions")
slide_footer(s6)

# Timeline bar
add_rect(s6, Inches(0.5), Inches(2.6), Inches(12.0), Inches(0.08), MID_BLUE)
timeline = [
    (Inches(0.9),  "1995", "Dept. of ISM & H\ncreated", ACCENT_GREEN),
    (Inches(3.6),  "2002", "National Policy on\nISM & Homeopathy", MID_BLUE),
    (Inches(7.0),  "2014", "AYUSH elevated to\nfull Ministry", ACCENT_ORG),
    (Inches(10.5), "2025", "WHO TM Strategy\n2025-2034 alignment", TEAL),
]
for tx, yr, lbl, col in timeline:
    shp = s6.shapes.add_shape(MSO_SHAPE.OVAL, tx - Inches(0.12), Inches(2.45), Inches(0.25), Inches(0.25))
    shp.fill.solid(); shp.fill.fore_color.rgb = col
    shp.line.fill.background(); shp.shadow.inherit = False
    add_text(s6, yr, tx - Inches(0.3), Inches(1.95), Inches(0.8), Inches(0.4),
             size=Pt(13), bold=True, color=col, align=PP_ALIGN.CENTER)
    add_text(s6, lbl, tx - Inches(0.5), Inches(2.85), Inches(1.2), Inches(0.7),
             size=Pt(11), color=GREY_TEXT, align=PP_ALIGN.CENTER)

add_text(s6, "Key Functions of Ministry of AYUSH",
         Inches(0.5), Inches(3.7), Inches(12), Inches(0.4),
         size=Pt(17), bold=True, color=DEEP_BLUE)

funcs = [
    ("Policy & Standards", "Formulates national policy, quality guidelines & pharmacopoeia standards for AYUSH drugs"),
    ("Regulation & Licensing", "Oversees >8,369 licensed ASU&H manufacturing units; 29 SDTLs & 81 approved labs"),
    ("Pharmacovigilance", "Monitors adverse events; ASU&H pharmacovigilance centres across India"),
    ("International Coordination", "Certifications: WHO CoPP, AYUSH Premium Mark (QCI), BIS collaborations"),
]
for i, (title, desc) in enumerate(funcs):
    fx = Inches(0.4) + i * Inches(3.2)
    add_rect(s6, fx, Inches(4.2), Inches(3.0), Inches(2.5), WHITE,
             line_rgb=MID_BLUE, line_width=Pt(1))
    add_rect(s6, fx, Inches(4.2), Inches(3.0), Inches(0.42), MID_BLUE)
    add_text(s6, title, fx + Inches(0.1), Inches(4.22), Inches(2.8), Inches(0.38),
             size=Pt(13), bold=True, color=WHITE)
    add_text(s6, desc, fx + Inches(0.1), Inches(4.72), Inches(2.8), Inches(1.85),
             size=Pt(12), color=DARK_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 7 — Quality Control of AYUSH
# ═══════════════════════════════════════════════════════════════════════════
s7 = prs.slides.add_slide(blank)
slide_bg(s7)
slide_header(s7, "Quality Control Mechanisms for AYUSH Drugs",
             "Standards, GMP, Pharmacopoeia & Pharmacovigilance")
slide_footer(s7)

qc_items = [
    (ACCENT_GREEN, "Pharmacopoeia Standards",
     ["Ayurvedic Pharmacopoeia of India (API)",
      "National Formulary of Ayurvedic Medicine (NFAM)",
      "Unani Pharmacopoeia of India (UPI)",
      "Siddha Pharmacopoeia of India",
      "Define: identity, purity & quality of raw materials"]),
    (MID_BLUE, "GMP Requirements",
     ["Schedule M-I: GMP for ASU manufacturing units",
      "Schedule T: Good Manufacturing Practice rules",
      ">8,369 licensed ASU&H manufacturing units",
      "Technically qualified staff mandatory (degree in Ayurveda/Siddha/Unani)",
      "Risk-based inspections by CDSCO & State Drug Controllers"]),
    (ACCENT_ORG, "Testing Laboratories",
     ["29 State Drug Testing Laboratories (SDTLs)",
      "81 labs approved under D&C Rules 1945",
      "27 SDTLs strengthened under National AYUSH Mission",
      "Private & central labs also approved",
      "Standards accreditation with BIS & QCI"]),
    (TEAL, "Pharmacovigilance & Certification",
     ["ASU&H Pharmacovigilance Centres — nationwide",
      "Monitor adverse events from AYUSH products",
      "Surveillance of misleading advertisements",
      "WHO Certification of Pharmaceutical Products (CoPP)",
      "AYUSH Premium Mark by Quality Council of India (QCI)"]),
]

for i, (col, title, points) in enumerate(qc_items):
    cx = Inches(0.35) + i * Inches(3.25)
    add_rect(s7, cx, Inches(1.35), Inches(3.1), Inches(5.5), WHITE,
             line_rgb=col, line_width=Pt(1.5))
    add_rect(s7, cx, Inches(1.35), Inches(3.1), Inches(0.48), col)
    add_text(s7, title, cx + Inches(0.1), Inches(1.38), Inches(2.9), Inches(0.42),
             size=Pt(13), bold=True, color=WHITE)
    add_multiline(s7, [(p, False, DARK_TEXT, 0) for p in points],
                  cx + Inches(0.15), Inches(1.95), Inches(2.85), Inches(4.7),
                  size=Pt(12), line_space=Pt(6))

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 8 — National AYUSH Mission
# ═══════════════════════════════════════════════════════════════════════════
s8 = prs.slides.add_slide(blank)
slide_bg(s8)
slide_header(s8, "National AYUSH Mission (2014–2021)",
             "Government Initiatives for Quality AYUSH Medicines")
slide_footer(s8)

add_rect(s8, Inches(0.4), Inches(1.35), Inches(12.5), Inches(0.7), DEEP_BLUE)
add_text(s8, "The National AYUSH Mission provided grant-in-aid and infrastructure support to ensure quality assurance across India's traditional medicine sector.",
         Inches(0.6), Inches(1.42), Inches(12.0), Inches(0.55),
         size=Pt(13), italic=True, color=WHITE)

activities = [
    (ACCENT_GREEN, "A", "Strengthening AYUSH\nPharmacies & DTLs",
     "Up-gradation to higher standards; state govt AYUSH pharmacies received grant-in-aid support."),
    (MID_BLUE, "B", "Pharmacovigilance\n& Ad Surveillance",
     "National centres to monitor adverse events and misleading advertising about AYUSH products."),
    (ACCENT_ORG, "C", "Regulatory Framework\nCapacity Building",
     "Technical human resource training for AYUSH drug inspectors and regulatory staff."),
    (TEAL, "D", "Standards &\nAccreditation",
     "Development of standards with BIS, QCI; AYUSH Premium Mark for third-party quality evaluation."),
]

for i, (col, ltr, title, desc) in enumerate(activities):
    ax = Inches(0.4) + i * Inches(3.2)
    ay = Inches(2.25)
    # Icon circle
    shp = s8.shapes.add_shape(MSO_SHAPE.OVAL, ax + Inches(1.0), ay, Inches(1.1), Inches(1.1))
    shp.fill.solid(); shp.fill.fore_color.rgb = col
    shp.line.fill.background(); shp.shadow.inherit = False
    add_text(s8, ltr, ax + Inches(1.0), ay, Inches(1.1), Inches(1.1),
             size=Pt(28), bold=True, color=WHITE, align=PP_ALIGN.CENTER)
    add_text(s8, title, ax, ay + Inches(1.2), Inches(3.0), Inches(0.8),
             size=Pt(13), bold=True, color=col, align=PP_ALIGN.CENTER)
    add_rect(s8, ax + Inches(0.1), ay + Inches(2.15), Inches(2.9), Inches(2.4), WHITE,
             line_rgb=col, line_width=Pt(1.2))
    add_text(s8, desc, ax + Inches(0.2), ay + Inches(2.25), Inches(2.7), Inches(2.2),
             size=Pt(12), color=GREY_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 9 — OTC: Current Regulatory Status
# ═══════════════════════════════════════════════════════════════════════════
s9 = prs.slides.add_slide(blank)
slide_bg(s9)
slide_header(s9, "OTC Medicines — Current Regulatory Status in India",
             "The Regulatory Gap")
slide_footer(s9)

# Key fact banner
add_rect(s9, Inches(0.4), Inches(1.35), Inches(12.5), Inches(0.85), RGBColor(0xFF, 0xF3, 0xCD))
add_rect(s9, Inches(0.4), Inches(1.35), Inches(0.15), Inches(0.85), ACCENT_ORG)
add_text(s9, "KEY FACT:  India currently has NO separate legally defined category for OTC medicines. Drugs not on a prescription schedule are sold OTC by default.",
         Inches(0.65), Inches(1.45), Inches(12.0), Inches(0.65),
         size=Pt(14), bold=False, color=RGBColor(0x7D, 0x41, 0x00))

# Two column layout
add_rect(s9, Inches(0.4), Inches(2.35), Inches(6.1), Inches(4.5), WHITE,
         line_rgb=LIGHT_RULE, line_width=Pt(1))
add_rect(s9, Inches(0.4), Inches(2.35), Inches(6.1), Inches(0.45), ACCENT_ORG)
add_text(s9, "How OTC is Currently Defined", Inches(0.55), Inches(2.38), Inches(5.8), Inches(0.4),
         size=Pt(15), bold=True, color=WHITE)

curr_pts = [
    ("Exclusion-based", True, MID_BLUE),
    ("If NOT on Schedule H, H1, X or G → can be sold OTC", False, DARK_TEXT),
    ("No dedicated OTC licensing guidelines", False, DARK_TEXT),
    ("No affirmative OTC registration process", False, DARK_TEXT),
    ("Schedule K", True, MID_BLUE),
    ("Household remedies e.g. Paracetamol, Eucalyptus oil,", False, DARK_TEXT),
    ("Liquid paraffin, Tinctures, Cough & cold formulations", False, DARK_TEXT),
    ("Non-chemists can dispense in areas <1,000 population", False, DARK_TEXT),
]
add_multiline(s9, [(t, b, c, 0) for t, b, c in curr_pts],
              Inches(0.55), Inches(2.9), Inches(5.8), Inches(3.7), size=Pt(13), line_space=Pt(5))

add_rect(s9, Inches(6.8), Inches(2.35), Inches(6.1), Inches(4.5), WHITE,
         line_rgb=LIGHT_RULE, line_width=Pt(1))
add_rect(s9, Inches(6.8), Inches(2.35), Inches(6.1), Inches(0.45), DEEP_BLUE)
add_text(s9, "Distribution & Access", Inches(6.95), Inches(2.38), Inches(5.8), Inches(0.4),
         size=Pt(15), bold=True, color=WHITE)

access_pts = [
    ("Sales channels (currently):", True, MID_BLUE),
    ("Licensed pharmacy/chemist shops only", False, DARK_TEXT),
    ("NOT available in supermarkets, convenience stores,", False, DARK_TEXT),
    ("petrol stations or online (unlike many nations)", False, DARK_TEXT),
    ("Emerging channel:", True, MID_BLUE),
    ("Post offices targeted for rural OTC distribution", False, DARK_TEXT),
    ("Faster, broader, economical reach to rural population", False, DARK_TEXT),
    ("Advertising of selected OTC products permitted", False, DARK_TEXT),
]
add_multiline(s9, [(t, b, c, 0) for t, b, c in access_pts],
              Inches(6.95), Inches(2.9), Inches(5.8), Inches(3.7), size=Pt(13), line_space=Pt(5))

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 10 — Key Drug Schedules
# ═══════════════════════════════════════════════════════════════════════════
s10 = prs.slides.add_slide(blank)
slide_bg(s10)
slide_header(s10, "Key Drug Schedules Relevant to OTC Classification",
             "Drugs & Cosmetics Act 1940 / Rules 1945")
slide_footer(s10)

schedules = [
    ("Schedule H",   DEEP_BLUE,   "Prescription-Only (Rx)",
     "NOT OTC",   RGBColor(0xC0, 0x39, 0x2B),
     "Antibiotics, antifungals, antivirals — require doctor's prescription. Must not be sold OTC."),
    ("Schedule H1",  MID_BLUE,    "Restricted Prescription",
     "NOT OTC",   RGBColor(0xC0, 0x39, 0x2B),
     "Specific antibiotics (3rd gen cephalosporins, carbapenems) and all anti-TB drugs. Stricter monitoring required."),
    ("Schedule X",   RGBColor(0x8E, 0x44, 0xAD), "Narcotics & Psychotropics",
     "NOT OTC",   RGBColor(0xC0, 0x39, 0x2B),
     "Narcotic and psychotropic substances. Special license needed; strict controls on storage, dispensing, records."),
    ("Schedule G",   ACCENT_ORG,  "Medical Supervision",
     "NOT OTC",   RGBColor(0xC0, 0x39, 0x2B),
     "Drugs that must carry 'To be sold under medical supervision' label. May not be freely self-medicated."),
    ("Schedule K",   ACCENT_GREEN, "Household Remedies",
     "OTC Eligible", ACCENT_GREEN,
     "Paracetamol, Eucalyptus oil, Liquid paraffin, Tinctures. Can be dispensed by non-chemists in areas < 1000 population."),
    ("Schedule N",   TEAL,        "Pharmacies",
     "Regulatory",  TEAL,
     "Minimum equipment standards and storage conditions for pharmacy premises."),
]

for i, (name, hdr_col, category, otc_status, status_col, desc) in enumerate(schedules):
    row = i // 2
    c = i % 2
    sx = Inches(0.4) + c * Inches(6.4)
    sy = Inches(1.45) + row * Inches(1.95)
    add_rect(s10, sx, sy, Inches(6.1), Inches(1.8), WHITE,
             line_rgb=hdr_col, line_width=Pt(1.5))
    add_rect(s10, sx, sy, Inches(1.4), Inches(1.8), hdr_col)
    add_text(s10, name, sx, sy + Inches(0.45), Inches(1.4), Inches(0.9),
             size=Pt(16), bold=True, color=WHITE, align=PP_ALIGN.CENTER)
    add_text(s10, otc_status, sx, sy + Inches(1.25), Inches(1.4), Inches(0.4),
             size=Pt(11), bold=True, color=status_col, align=PP_ALIGN.CENTER)
    add_text(s10, category, sx + Inches(1.5), sy + Inches(0.07), Inches(4.4), Inches(0.38),
             size=Pt(13), bold=True, color=hdr_col)
    add_text(s10, desc, sx + Inches(1.5), sy + Inches(0.5), Inches(4.45), Inches(1.2),
             size=Pt(11.5), color=GREY_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 11 — Push for Formal OTC Framework
# ═══════════════════════════════════════════════════════════════════════════
s11 = prs.slides.add_slide(blank)
slide_bg(s11)
slide_header(s11, "Push for a Formal OTC Framework in India",
             "Ahooja Committee | Drugs Consultative Committee | MoHFW Draft Rules")
slide_footer(s11)

# Ahooja Committee box
add_rect(s11, Inches(0.4), Inches(1.35), Inches(5.9), Inches(5.5), WHITE,
         line_rgb=ACCENT_GREEN, line_width=Pt(2))
add_rect(s11, Inches(0.4), Inches(1.35), Inches(5.9), Inches(0.5), ACCENT_GREEN)
add_text(s11, "Ahooja Committee Recommendations",
         Inches(0.55), Inches(1.38), Inches(5.6), Inches(0.44),
         size=Pt(15), bold=True, color=WHITE)

steps = [
    "1. Define and prepare an initial list of OTC drugs",
    "2. Regulate the Rx-to-OTC switch process",
    "3. Regulate new OTC drug approvals",
    "4. Regulate distribution & sale of OTC drugs",
    "5. Regulate advertising of OTC drugs",
]
add_multiline(s11, [(s, False, DARK_TEXT, 0) for s in steps],
              Inches(0.55), Inches(2.0), Inches(5.6), Inches(3.5), size=Pt(14), line_space=Pt(10))

add_rect(s11, Inches(0.55), Inches(5.25), Inches(5.6), Inches(1.3), LIGHT_BG)
add_text(s11, "Approved by Drugs Consultative Committee (DCC)",
         Inches(0.65), Inches(5.35), Inches(5.4), Inches(0.4),
         size=Pt(13), bold=True, color=DEEP_BLUE)
add_text(s11, "Recommendations form the basis for India's forthcoming formal OTC regulatory framework.",
         Inches(0.65), Inches(5.75), Inches(5.4), Inches(0.7),
         size=Pt(12), color=GREY_TEXT)

# Right side: MoHFW Draft + Rx to OTC switch
add_rect(s11, Inches(6.6), Inches(1.35), Inches(6.3), Inches(2.5), WHITE,
         line_rgb=ACCENT_ORG, line_width=Pt(2))
add_rect(s11, Inches(6.6), Inches(1.35), Inches(6.3), Inches(0.5), ACCENT_ORG)
add_text(s11, "MoHFW Draft Rules — 16 Identified OTC Drugs",
         Inches(6.75), Inches(1.38), Inches(6.0), Inches(0.44),
         size=Pt(15), bold=True, color=WHITE)
add_text(s11, "For the FIRST TIME, India's MoHFW draft rules formally identified 16 drugs as OTC candidates (including antifungals). The term 'OTC' recommended as a DISTINCT drug category in Indian law.",
         Inches(6.75), Inches(1.95), Inches(6.0), Inches(1.7),
         size=Pt(13), color=DARK_TEXT)

add_rect(s11, Inches(6.6), Inches(4.05), Inches(6.3), Inches(2.8), WHITE,
         line_rgb=MID_BLUE, line_width=Pt(2))
add_rect(s11, Inches(6.6), Inches(4.05), Inches(6.3), Inches(0.5), MID_BLUE)
add_text(s11, "Rx-to-OTC Switch Criteria",
         Inches(6.75), Inches(4.08), Inches(6.0), Inches(0.44),
         size=Pt(15), bold=True, color=WHITE)

criteria = [
    "Extent of evidence for safety",
    "Wide therapeutic index (large safety margin)",
    "Need for patient accessibility",
    "Non-habit-forming nature",
    "Existing supply-chain mechanism",
    "Socio-economic conditions of India",
]
add_multiline(s11, [(c, False, DARK_TEXT, 0) for c in criteria],
              Inches(6.75), Inches(4.65), Inches(6.0), Inches(2.05), size=Pt(13), line_space=Pt(5))

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 12 — Risks of Unregulated OTC
# ═══════════════════════════════════════════════════════════════════════════
s12 = prs.slides.add_slide(blank)
slide_bg(s12)
slide_header(s12, "Risks of the Current Unregulated OTC Environment",
             "QUM Concerns with Absence of a Formal OTC Framework")
slide_footer(s12)

add_rect(s12, Inches(0.4), Inches(1.35), Inches(12.5), Inches(0.65), MID_BLUE)
add_text(s12, "Benefits of OTC access: faster & cheaper access, reduced burden on healthcare, consumer empowerment",
         Inches(0.6), Inches(1.42), Inches(12.0), Inches(0.5),
         size=Pt(13), bold=False, color=WHITE)

risks = [
    (RGBColor(0xC0, 0x39, 0x2B), "Excessive Dosage",
     "Without pharmacist oversight, patients may exceed recommended doses, especially with analgesics (paracetamol, NSAIDs) and antihistamines."),
    (RGBColor(0xE6, 0x7E, 0x22), "Polypharmacy",
     "Self-medication with multiple OTC products simultaneously increases risk of drug-drug interactions without professional review."),
    (RGBColor(0x8E, 0x44, 0xAD), "Drug Abuse",
     "Antihistamines, cough suppressants (codeine-based), and some analgesics are prone to misuse when freely available."),
    (RGBColor(0x16, 0xA0, 0x85), "Special Populations",
     "Pediatric, geriatric, pregnant, and renally impaired patients face heightened risk with unsupervised OTC use."),
    (RGBColor(0x1A, 0x3A, 0x5C), "Drug Interactions",
     "OTC + prescription drug combinations can cause serious interactions (e.g. NSAIDs with anticoagulants, antihistamines with CNS depressants)."),
    (RGBColor(0x27, 0xAE, 0x60), "Spurious Products",
     "Absence of strict OTC quality standards allows substandard/counterfeit products to enter the supply chain under OTC-type categories."),
]

for i, (col, title, desc) in enumerate(risks):
    row = i // 3
    c = i % 3
    rx = Inches(0.4) + c * Inches(4.25)
    ry = Inches(2.15) + row * Inches(2.35)
    add_rect(s12, rx, ry, Inches(4.0), Inches(2.15), WHITE,
             line_rgb=col, line_width=Pt(1.8))
    add_rect(s12, rx, ry, Inches(4.0), Inches(0.45), col)
    add_text(s12, title, rx + Inches(0.12), ry + Inches(0.06), Inches(3.7), Inches(0.38),
             size=Pt(14), bold=True, color=WHITE)
    add_text(s12, desc, rx + Inches(0.12), ry + Inches(0.55), Inches(3.75), Inches(1.5),
             size=Pt(12), color=GREY_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 13 — India vs Global Comparison
# ═══════════════════════════════════════════════════════════════════════════
s13 = prs.slides.add_slide(blank)
slide_bg(s13)
slide_header(s13, "India vs Global OTC Regulatory Comparison",
             "Current Status & Way Forward")
slide_footer(s13)

# Table header
headers = ["Feature", "India (Current)", "Developed Countries"]
col_x2  = [Inches(0.4), Inches(4.0), Inches(8.9)]
col_w2  = [Inches(3.5), Inches(4.8), Inches(4.0)]
hdr_y   = Inches(1.4)
for ci, (hdr, cx, cw) in enumerate(zip(headers, col_x2, col_w2)):
    bc = DEEP_BLUE if ci == 0 else (ACCENT_ORG if ci == 1 else ACCENT_GREEN)
    add_rect(s13, cx, hdr_y, cw, Inches(0.5), bc)
    add_text(s13, hdr, cx + Inches(0.1), hdr_y + Inches(0.06), cw - Inches(0.2), Inches(0.38),
             size=Pt(14), bold=True, color=WHITE)

rows13 = [
    ("Defined OTC category in law",    "No (draft rules pending)",        "Yes — legally defined"),
    ("Rx-to-OTC switch pathway",       "Absent / informal",               "Formal, evidence-based"),
    ("Sale in non-pharmacy outlets",   "Restricted (pharmacy only)",      "Permitted for many products"),
    ("OTC labeling standards",         "No specific OTC label standard",  "Mandatory patient leaflets"),
    ("Advertising regulation",         "Partial (some products allowed)", "Comprehensive framework"),
    ("Pharmacovigilance for OTC",      "Limited / developing",            "Established post-market surveillance"),
    ("Essential medicines OTC list",   "Not formally designated",         "34 countries include herbal OTCs"),
]

for ri, row in enumerate(rows13):
    ry2 = Inches(1.9) + ri * Inches(0.62)
    bg2 = LIGHT_BG if ri % 2 == 0 else WHITE
    for ci2, (cell, cx2, cw2) in enumerate(zip(row, col_x2, col_w2)):
        add_rect(s13, cx2, ry2, cw2, Inches(0.6), bg2)
        fc2 = DEEP_BLUE if ci2 == 0 else (RGBColor(0xA0, 0x40, 0x00) if ci2 == 1 else RGBColor(0x14, 0x60, 0x2E))
        add_text(s13, cell, cx2 + Inches(0.1), ry2 + Inches(0.08), cw2 - Inches(0.15), Inches(0.48),
                 size=Pt(12), bold=(ci2 == 0), color=fc2)

add_text(s13, "Global: 125 countries have OTC registration systems (2018);  79 countries sell herbal medicines OTC;  34 countries include herbal OTC in essential medicines list",
         Inches(0.4), Inches(6.38), Inches(12.5), Inches(0.45),
         size=Pt(11), italic=True, color=GREY_TEXT)

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 14 — Way Forward & Summary
# ═══════════════════════════════════════════════════════════════════════════
s14 = prs.slides.add_slide(blank)
slide_bg(s14)
slide_header(s14, "Summary & Way Forward",
             "QUM Regulatory Aspects — Complementary & OTC Medicines in India")
slide_footer(s14)

# Two summary boxes
add_rect(s14, Inches(0.4), Inches(1.35), Inches(6.0), Inches(5.5), WHITE,
         line_rgb=ACCENT_GREEN, line_width=Pt(2))
add_rect(s14, Inches(0.4), Inches(1.35), Inches(6.0), Inches(0.5), ACCENT_GREEN)
add_text(s14, "Complementary Medicines (AYUSH)", Inches(0.55), Inches(1.38), Inches(5.7), Inches(0.44),
         size=Pt(15), bold=True, color=WHITE)
cm_pts = [
    "Governed by D&C Act 1940 (Ch. IVA) + Indian Medicines Central Council Act 1970",
    "Ministry of AYUSH (2014) oversees all regulation & standards",
    ">8,369 licensed manufacturing units; 29 SDTLs; 81 approved labs",
    "Pharmacopoeia standards: API, UPI, Siddha Pharmacopoeia",
    "GMP: Schedule T & M-I",
    "Pharmacovigilance centres for ASU&H drugs nationwide",
    "Certifications: WHO CoPP, AYUSH Premium Mark (QCI)",
    "Aligned with WHO TM Strategy 2025–2034",
    "GAP: Limited inspectors relative to unit volume",
]
add_multiline(s14, [(p, False, DARK_TEXT, 0) for p in cm_pts],
              Inches(0.55), Inches(1.95), Inches(5.7), Inches(4.7), size=Pt(12.5), line_space=Pt(5))

add_rect(s14, Inches(6.8), Inches(1.35), Inches(6.1), Inches(5.5), WHITE,
         line_rgb=ACCENT_ORG, line_width=Pt(2))
add_rect(s14, Inches(6.8), Inches(1.35), Inches(6.1), Inches(0.5), ACCENT_ORG)
add_text(s14, "OTC Medicines", Inches(6.95), Inches(1.38), Inches(5.8), Inches(0.44),
         size=Pt(15), bold=True, color=WHITE)
otc_pts = [
    "No separate OTC category in Indian law — defined by exclusion",
    "Schedule K provides the closest OTC-like list (Paracetamol, etc.)",
    "Ahooja Committee + DCC outlined 5-point OTC framework",
    "MoHFW draft rules: first time 16 drugs identified as OTC",
    "No formal Rx-to-OTC switch pathway yet",
    "Advertising of selective OTC products permitted",
    "Sales restricted to licensed pharmacies only",
    "Post offices emerging as rural OTC access channel",
    "Risks: polypharmacy, abuse, interactions, special populations",
]
add_multiline(s14, [(p, False, DARK_TEXT, 0) for p in otc_pts],
              Inches(6.95), Inches(1.95), Inches(5.8), Inches(4.7), size=Pt(12.5), line_space=Pt(5))

# ═══════════════════════════════════════════════════════════════════════════
#  SLIDE 15 — Thank You / References
# ═══════════════════════════════════════════════════════════════════════════
s15 = prs.slides.add_slide(blank)
add_rect(s15, 0, 0, W, H, DEEP_BLUE)
add_rect(s15, 0, Inches(5.0), W, Inches(2.5), MID_BLUE)
add_rect(s15, Inches(1.5), Inches(3.0), Inches(0.12), Inches(1.8), ACCENT_GREEN)

add_text(s15, "Thank You",
         Inches(1.8), Inches(2.0), Inches(10), Inches(1.4),
         size=Pt(54), bold=True, color=WHITE, align=PP_ALIGN.LEFT)
add_text(s15, "Regulatory Aspects of QUM in India",
         Inches(1.8), Inches(3.2), Inches(10), Inches(0.65),
         size=Pt(20), color=LIGHT_RULE, align=PP_ALIGN.LEFT)

refs = [
    "Drugs & Cosmetics Act 1940 (as amended 2009) — Government of India",
    "Ministry of AYUSH, Govt. of India — cdsco.gov.in / ayush.gov.in",
    "PMC10201516 — Regulatory, safety and economic considerations of OTC medicines in India (2023)",
    "WHO Traditional Medicine Strategy 2025–2034",
    "Ahooja Committee Report on OTC Drug Policy — MoHFW, India",
]
add_multiline(s15, [(r, False, LIGHT_RULE, 0) for r in refs],
              Inches(1.0), Inches(5.15), Inches(11.5), Inches(2.0), size=Pt(11), line_space=Pt(6))

# ── Save ─────────────────────────────────────────────────────────────────
out = "/tmp/workspace/qum-india-ppt/QUM_India_Regulatory_Aspects.pptx"
buf = BytesIO()
prs.save(buf)
with open(out, "wb") as f:
    f.write(buf.getvalue())
print(f"Saved: {out}")
print(f"Slides: {len(prs.slides)}")

Running Command

cd /tmp/workspace/qum-india-ppt && python create_ppt.py 2>&1

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QUM India Regulatory Aspects

Presentation · PPTX

What's inside — 15 slides, 16:9 widescreen, professional colour design:

#	Slide
1	Title Slide — Regulatory Aspects of QUM in India
2	Agenda — colour-coded by topic (green = complementary, orange = OTC, blue = comparison)
3	CAM Introduction — definition, types, complementary vs alternative comparison table
4	WHO Strategy — 4 pillars of WHO TM Strategy 2025-2034
5	Legislative Framework — 6 key laws (D&C Act, Indian Medicines Central Council Act, etc.)
6	Ministry of AYUSH — timeline (1995 → 2025) + 4 key functions
7	Quality Control Mechanisms — Pharmacopoeia, GMP, Labs, Pharmacovigilance
8	National AYUSH Mission 2014-2021 — 4 activity areas (A-D)
9	OTC Current Status — the regulatory gap, Schedule K, distribution channels
10	Key Drug Schedules — H, H1, X, G, K, N with OTC eligibility
11	Formal OTC Framework — Ahooja Committee 5 steps, MoHFW draft rules, Rx-to-OTC switch criteria
12	Risks of Unregulated OTC — 6 risk categories (dosage, polypharmacy, abuse, special populations, etc.)
13	India vs Global Comparison — feature-by-feature table
14	Summary & Way Forward — dual-column summary for both topics
15	Thank You / References

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