Question : VIOLATION OF DRUGS AND COSMETIC ACT



(a) whether Government are aware that in World Bank assisted tender for T.B. sub-standard products are being supplied by the approved supplier;

(b) whether the supplies received are tested at NIPER for the quality;

(c) whether supplies are made without batch numbers violating of Drugs and Cosmetics Act; and

(d) if so, the report is likely to be submitted to Parliament on this national issue?

Answer given by the minister


THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A. RAJA)

(a): Procurement of anti-TB drugs and binocular microscopes required for World Bank assisted Revised National TB Control Programme is made by an independent procurement agency engaged with the approval of the World Bank. All procurements are made in accordance with the technical specifications prescribed in the tender document. All products, before issue, are inspected and tested by the Procurement Agency.

(b): The supplies are got tested by Procurement Agency in Government approved Testing Laboratories for assurance of quality before dispatch clearance is issued to the approved suppliers. Testing of the products at any specific institution is not prescribed. Moreover, NIPER is neither a Government Analyst Lab nor an approved private Drug Testing Lab.

(c): As per the technical specifications prescribed for anti-TB drugs in accordance with the provisions of the Drugs and Cosmetics Act, it is mandatory to indicate batch numbers, date of manufacturing and date of expiry on the blisters or packages. Supply of drugs are made directly from manufacturer to project districts/GMSDs. No complaint regarding batch numbers of supplies has been reported from any of the project districts or GMSDs.

(d): Does not arise in view of (a) to (c) above.