The government may make it mandatory for import license holders to maintain control samples of imported drugs.
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.
The DTAB says of the proposed change: “The licensee shall maintain reference samples from each batch of the drugs imported by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed in the batch.”
“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. In 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.”
A senior health official explained that, previously, the rules applied to indigenous manufacturers marketing drugs in the country, adding, “There was no such condition available in the import licence under the Drugs and Cosmetics Rules, 1945.”
“So, in a situation where there is any spurious, misbranded or sub-standard drug found in the market, it becomes very difficult to verify the authenticity of such drugs, as the control samples of such imported drugs are not available with the import licence holder,” noted the DTAB.
The move, which offers much needed protection to patients, and teeth to regulatory authorities in India, comes months after the Union Health Ministry found Johnson & Johnson Private Limited guilty of supplying faulty hip implants in India, and ordered the company to pay over ₹74 lakh to a Mumbai-based patient as compensation.
Changes ahead
Meanwhile, the DTAB has also agreed to amend the Medical Devices Rules, 2017 to incorporate the names, qualifications and experiences of competent technical staff responsible for the manufacture and testing of medical devices, and the scope of accreditation in the respective forms.
This comes alongside the proposal for an additional over 700 staff members to monitor the sale, use, etc., of medical devices.
