Recently, the Drugs Technical Advisory Board (DTAB) recommended the inclusion of all antibiotics in the definition of new drugs in the New Drugs and Clinical Trial (NDCT) Rules, 2019.
Tightened Antibiotic Regulations Proposed to Combat Antimicrobial Resistance
- Aim: The recommendation to the Drugs Consultative Committee (DCC) is aimed at curbing the growing antimicrobial resistance which is now recognised as a public health threat globally.
- Strengthening regulation: This move aims to strengthen control over the manufacturing, marketing, and sale of antibiotics, requiring Central government clearance instead of State authorities and allowing purchases only through prescription.
- Threat of AMR: AMR is making diseases like urinary tract infections and pneumonia resistant to commonly used antibiotics in India.
What is a New Drug under the NDCT Rules 2019?
- Definition of New Drug: A “new drug” is one that has not been significantly used or approved as safe and effective by the Central Licensing Authority in India.
- Modified Claims: It includes drugs already approved but now proposed with modified claims, such as new indications, dosage forms, or administration routes.
- Fixed-Dose Combinations: A new drug can be a fixed-dose combination of approved drugs, proposed for the first time or with changes in the ratio of ingredients.
- Novel Drug Delivery: A drug with a modified or sustained release form or a novel delivery system is also considered a new drug.
- Biological Products: Vaccines, r-DNA products, monoclonal antibodies, and gene therapy products are always classified as new drugs.
- Time Frame: Except for biologicals and novel forms, drugs remain “new drugs” for four years from the date of approval.
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About Drugs Technical Advisory Board
- DTAB is the highest decision-making body on technical matters related to drugs in the country.
- Statutory Body: It was Constituted under the Drugs and Cosmetics Act, 1940 and It is part of the Central Drugs Standard Control Organization (CDSCO).
- Nodal Ministry: Ministry of Health and Family Welfare.
- Function: It advises the Central Government and the State Governments on technical matters arising out of the administration of the Drugs and Cosmetics Act, of 1940 and to carry out the other functions assigned to it by this Act.
Central Drugs Standard Control Organization (CDSCO)
- The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, is India’s National Regulatory Authority (NRA) for drugs and cosmetics.
- It enforces the Drugs & Cosmetics Act, 1940 to ensure patient safety, efficacy, and product quality.
- CDSCO oversees the approval of drugs, clinical trials, and the quality of imported drugs.
- It works with state regulators to ensure uniform enforcement and issues licenses for specialized products like blood products, vaccines, and IV fluids.
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October 17, 2024
