Drugs Technical Advisory Board:
The Drugs Technical Advisory Board (DTAB) has recommended the inclusion of all antibiotics in the definition of new drugs in the New Drugs and Clinical Trial (NDCT) Rules, 2019.
- Drugs Technical Advisory Board is the highest statutory decision-making body on technical matters related to drugs in India.
- It is established as per the Drugs and Cosmetics Act, 1940.
- It is part of the Central Drugs Standard Control Organization (CDSCO).
- 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.
- Nodal Ministry:Ministry of Health and Family Welfare.
- According to Rule 122 E of the Drug and Cosmetic Rules 1945, a new drug can be one which has not been used in the country and has not been recognised as effective and safe by the licensing authority for the proposed claims.
- It could also be an approved drug with modified or new claims including indications, dosage, and new route of administration.\
- If brought into the new drug bracket, the manufacturing, marketing, and sale of antibiotics will be documented.
- Also, the manufacturing and marketing clearance will have to be obtained from the Central government instead of State drug administration, and patients will be able to buy antibiotics only on prescription.
