Drug & Cosmetic Act And Rules: INDIA

What are the Drug & Cosmetic Act and Rules 1940?

The Drug & Cosmetic Act and Rules 1940 was enacted by the Department of Health under the Ministry of Health and Family Welfare after receiving the consent of the Governor General on April 10, 1940, and came into force on April 1, 1947. This Act regulates the manufacture, distribution and sale of drugs, biosimilars, medical devices and importers in India. The first and foremost objective of the Act is to ensure that the drugs, biosimilars and medical devices sold in India are safe, effective and conform to state quality standards. The original version of the Act has 5 Chapters, 38 Sections and 2 schedules.

Health is a Fundamental Right granted by the Constitution of India. The Drugs Control Administration aims to assure the availability of drugs & Cosmetics of proven quality, efficacy and safety at prices as announced. In addition, it also guards the public against the exploitation of misleading advertisements.

The government of India establishes the Rules through the Drugs and Cosmetics Act of 1940. The Rules have also been amended from time to time to meet the needs of the time and to rectify any deficiencies noticed during the implementation:

  • The Drugs and Cosmetics Rules, 1945
  • The New Drugs and Cosmetics Rules, 2019
The goals of the Drug & Cosmetic Act and Rules 1940 are:
  • To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
  • Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
  • To avoid substandard drugs, presumably to maintain high standards of medical treatment.
  • To regulate the manufacture and sale of Ayurvedic, Siddha and Unani medicines.
  • To establish the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.
Schedules of Drug & & Cosmetic Act 1940

First Schedule- Names of books under Ayurvedic and Siddha systems.
Second Schedule– Standard to be compiled with imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distribution.
Drug & Cosmetic Rules, 1945
The Drugs and Cosmetics Rules of 1945 are the rules the government of India established through the Drugs and Cosmetics Act of 1940. These rules catogrize drugs under given schedules and present guidelines for each schedule’s storage, sale, display, and prescription. The drug rules were promulgated in December 1945, and enforcement started in 1947. 
The rules comprise 19 Parts and 20 schedules. Parts IV, part VII, part VIII and part IX state rules and regulations for importing, manufacturing, and selling drugs and biological and medical devices. Part X explains provisions solely applicable to biological products. Part X describes naming, container, labeling, and standards related to the quality and testing of biological products.
Schedules of Drug & & Cosmetic Rule 1945
And enforcement started in 1947. These Rules have been amended from time to time to meet the needs and to rectify any shortcomings in the process.
SCHEDULE – A – FORMS
SCHEDULE – B – Fee for Test or Analysis
SCHEDULE- C –Biological & Special Products
SCHEDULE – C1- Other Special Products
SCHEDULE- D –Exemptions u. c. III
SCHEDULE- D(I)- Information –Mfg. Unit Registration for import D&C RULES contd.,
Schedule – D(II)-Information –product Registration for import
SCHEDULE- E(1) – Poisonous Substances
SCHEDULE F – PART I to PART XII(A) OMITTED
PART XII – B – Blood &Blood BANKS
PART XII – C – BLOOD PRODUCTS.
SCHEDULE F(1) – Bacterial Vaccines, Sera
SCHEDULE F(II) – Standards, Surgical Dressings
SCHEDULE F(III) – Standards Umbilical Tapes
SCHEDULE FF – Standards Ophthalmic preparations
SCHEDULE G – Drugs to be used under the supervision of Regd.Medical Practitioners.
SCHEDULE H – Prescription Drugs
SCHEDULE J – Prohibition of advertisements on drugs.
SCHEDULE K – Exemptions-Chap IV
SCHEDULE L1 – Good Laboratory practices.
SCHEDULE M – Good Mfg Practices
SCHEDULE M-I –GMP Homeo Medicines
SCHEDULE M II – Factory-cosmetics
SCHEDULE M III -Factory Medical Devices
SCHEDULE N – Pharmacy- requirements
SCHEDULE O – Standards for Disinfectant fluids
SCHEDULE P – Life Period of drugs
SCHEDULE P 1 –Pack size of drugs
SCHEDULE Q– Colours Cosmetics
SCHEDULE R- Standards for Condoms
SCHEDULE R1-Stds for Medical Devices
SCHEDULE S– Standards for cosmetics
SCHEDULE T-GMP- Ayurvedic Drugs
SCHEDULE U – RECORDS-DRUGS
SCHEDULE U1- Records Cosmetics
SCHEDULE V- Stds for P&P Medicines
SCHEDULE X- Class of Drugs- XRx
SCHEDULE Y- Requirements and Guidelines for permission to import and manufacture New Drugs for sale or undertake Clinical Trials.
New Drugs and Clinical Trials Rules 2019
The New drugs and Clinical trials rule 2019 (New rules) was introduced on March 19, 2019, by the Government of India vide Gazette of India Notification #227 dated March 19, 2019. The new rules aim to promote clinical research in the country and will change the regulatory landscape for the approval of new drugs and the conduct of clinical trials in the country. The new regulations cover provisions for promoting clinical research and complex topics such as orphan drugs, post-trial access, and pre and post-submission meetings. The new rules are structured around 13 chapters (including 107 rules) and eight schedules. The new rules will apply to all biological products (human vaccines and rDNA products) except for stem cell and cell-based Products and Veterinary vaccines.

Reference: https://cliniexperts.com/india-regulatory-bodies/cdsco/drug-and-cosmetic-act-1940_drugs-and-cosmetic-rules-1945_drugs-and-cosmetic-rules-2019/
http://www.mcrhrdi.gov.in/drugs/material/drugs%20control.pdf
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  • On January 31, 2023
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