What is Drug & Cosmetic Act and Rules

What is Drug & Cosmetic Act and Rules

The Drug and Cosmetics Act, 1940 was enacted by the Department of Health under the Ministry of Health and Family Welfare after receiving the assent of the Governor General on April 10, 1940 and came into force on April 1, 1947.It regulates the import, manufacture, distribution and sale of drugs, biosimilars and medical devices. The primary 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 Act has 5 Chapters, 38 Sections and 2 schedules.

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

  1. The Drugs and Cosmetics Rules, 1945
  2. The New Drugs and Cosmetics Rules, 2019

Objectives of Drug & Cosmetic Act 1940

  1. To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
  2. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
  3. To prevent substandard in drugs, presumably for maintaining high standards of medical treatment.
  4. To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
  5. To establish 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 by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distribution.

1. Drug & Cosmetic Act 1940 with respect to cosmetics

Drugs and Cosmetic Act defines cosmetic as “cosmetic” means any article intended to be rubbed, poured sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. It Regulate the import, manufacture and sale or distribution of drugs and cosmetics through Licenses and permits etc.

2. Drug & Cosmetic Act 1940 with respect to Biologicals

Drugs and Cosmetics Act and Rules made there under has stated rules for import, manufacture and sale of biological products in India:

  1. Manufacturing for the purpose of Examination, test or analysis of vaccines, r-DNA products, Stem cells and Cell based products, Blood & Blood Products, Veterinary vaccines.
  2. Requirement of Clinical Trials in human and Field Trials in animals before marketing authorization.
  3. Issuance of Registration Certificate, Import License and Test Licence.
  4. Manufacturing license under CLAA Scheme for human and veterinary vaccines, rDNA products and blood products.
  5. Export NOC and Re-packaging Permission under Rule 37 for human and veterinary vaccines and rDNA products.
  6. Requirements of Shelf life and storage conditions for biological products.
  7. Reduced requirements for preclinical and clinical data based on demonstration of similarity in the comparative assessment
  8. Conditions for waiving local clinical trials to provide patients with earlier access to biological products.
  9. The time-bound review of applications.

3. Drug & Cosmetic Act 1940 with respect to Drugs:

Drugs and Cosmetics Act and Rules made there under has stated rules for import, manufacture and sale of biological products in India:

  1. Grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis).
  2. Approval of Clinical Trials in human and Field Trials in animals.
  3. Grant of Marketing Authorization of drugs.
  4. Grant of Registration Certificate, Import License and Test Licence.
  5. Issuance of Form 28-D Licensing under CLAA Scheme for drugs.
  6. Issuance of Export NOC and Permission under Rule 37 for.
  7. Shelf life and storage conditions requirements
  8. Conditions for waiving local clinical trials.
  9. The time-bound review of applications.

4. Drug & Cosmetic Act 1940 with respect to Medical Device: 

In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA). Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and Drugs and Cosmetics runs under 1945.

Drug & Cosmetic Rules, 1945

The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule. The drug rules were promulgated in December 1945 and enforcement of these rules started in 1947. The rules comprise of 19 Parts and 20 schedules. The part IV, part VII, part VIII and part IX states rules and regulations for Import, manufacturing and sale of drugs, biological and medical devices. The part X explains provisions solely applicable to biological products. The Part X describes naming, container, labelling, standards related to quality and testing of biological products.

Schedules of Drug & & Cosmetic Rule 1945

and enforcement started in 1947. The Rules have been amended time to time to meet the needs and to rectify any shortcomings in the process.

SCHEDULE – A – FORMS
SCHDULE – 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 on 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 Guide- – lines for permission to import and/or manufacture of New Drugs for sale or undertake Clinical Trials.

New Drugs and Clinical Trials Rules 2019

The New drugs and Clinical trials rules 2019 (New rules) were introduced on 19th March 2019 by Government of India vide Gazette of India Notification #227 dated 19 March 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 conduct of clinical trials in the country. The new regulations cover provision for promoting clinical research as well as complex topics such as orphan drug, post-trial access, and pre and post submission meeting. 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.

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