After J&J case, govt. treads carefully

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  1. The Drugs Technical Advisory Board (DTAB) has recommended amendment to Rule 26 of the Drugs and Cosmetics Rules,1945,which deals with conditions under import licences.
  2. The proposed amendment makes it mandatory for import license holders to maintain control samples of imported drugs.In case of drugs bearing an expiry date on the label,the reference samples shall be maintained for a period of three months beyond the date of expiry or potency.
  3. Further,In the case of drugs where no date of expiry or potency is specified on the label,the reference samples shall be maintained for a period of three years from the date of manufacture.
  4. This move comes after the Government had found Johnson & Johnson guilty of supplying faulty hip implants in India and had ordered the company to pay over ₹74 lakh to a Mumbai-based patient as compensation.
  5. DTAB is highest statutory decision-making body on technical matters related to drugs in the country.It was constituted as per the Drugs and Cosmetics Act,1940.It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.