Context
- The Central Government has amended the Drugs Rules, 1945 to strengthen the regulatory framework for advanced and emerging medical technologies.
- The amendment brings stem cell-derived products, gene therapeutic products, and xenografts under the purview of the Central Licensing Approval Authority (CLAA).
- It also expands the scope of CLAA to regulate other emerging biological products.
Key Highlights
- Uniform Regulation: Establishes a centralized approval mechanism for advanced biological products across India.
- Expanded CLAA Jurisdiction: The CLAA will now regulate:
- Stem cell-derived products
- Gene therapeutic products
- Xenografts
- Vaccines
- Large Volume Parenterals (LVPs)
- Recombinant DNA (r-DNA) based medicines
- Objective: Ensure quality, safety, efficacy, and uniform standards for emerging therapies.
What is the Central Licensing Approval Authority (CLAA)?
- Constituted under the Drugs and Cosmetics Rules, 1945.
- Functions under the Central Drugs Standard Control Organisation (CDSCO).
- Grants centralized licences for specified categories of drugs requiring higher regulatory oversight.
- Ensures uniform standards across all States and Union Territories.
About Drugs and Cosmetics Act, 1940
- Primary legislation regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India.
- Objective:
- Ensure safety, efficacy, and quality of drugs.
- Prevent manufacture and sale of substandard or adulterated medicines.
- Administered by:
- Ministry of Health and Family Welfare
- Central Drugs Standard Control Organisation (CDSCO)
Core Comparison: Act vs. Rules
| Feature | Drugs and Cosmetics Act, 1940 | Drugs and Cosmetics Rules, 1945 |
| Nature of Law | Parent Legislation / Statutory Law enacted by the Parliament (Imperial Legislative Council pre-independence). | Subordinate / Delegated Legislation framed by the Executive (Ministry of Health and Family Welfare). |
| Primary Purpose | Defines broad legal mandates, offenses, penalties, jurisdictions, and overarching objectives. | Outlines the exact procedures, forms, fees, conditions, and technical standards required to implement the Act. |
| Amendment Process | Requires a formal amendment bill to be passed by Parliament. | Can be amended directly by the Executive/Ministry via gazette notifications (often in consultation with statutory boards). |
With reference to the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, consider the following statements:
1. The Drugs and Cosmetics Act, 1940 is the parent legislation that provides the legal framework for regulating drugs and cosmetics in India.
2. The Drugs and Cosmetics Rules, 1945 can be amended by the Executive through gazette notifications.
3. The Central Licensing Approval Authority (CLAA) functions under the Ministry of Commerce and Industry.
4. The recent amendment to the Drugs Rules, 1945 brings stem cell-derived products, gene therapeutic products, and xenografts under the purview of the CLAA.
Which of the statements given above are correct?
(a) 1, 2 and 4 only
(b) 1 and 3 only
(c) 2, 3 and 4 only
(d) 1, 2, 3 and 4
Answer: A
Explanation:
• Statement 1 is Correct: The Drugs and Cosmetics Act, 1940 is the parent legislation governing drugs and cosmetics in India.
• Statement 2 is Correct: The Drugs and Cosmetics Rules, 1945 are subordinate legislation and can be amended by the Executive through gazette notifications.
• Statement 3 is Incorrect: The Central Licensing Approval Authority (CLAA) functions under the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, not the Ministry of Commerce and Industry.
• Statement 4 is Correct: The recent amendment brings stem cell-derived products, gene therapeutic products, and xenografts under the CLAA's regulatory framework.