Health Ministry is planning to amend the rules to enable the drug inspectors to collect samples for tests and analysis from the retail shops with a view to further streamlining the monitoring of drugs movement and the quality of medicines.
According to the existing provision under the Drugs and Cosmetics Rules there is no specific provision prescribed to draw samples for tests and analysis from the retail shops. The move is hence to amend the Rule 51 of the D&C Rules accordingly.
The issue was brought up for discussion in the last meeting of the Drugs Consultative Committee which in principle approved the amendment to the concerned rule. However, it was referred for further examination by an expert panel for finalizing the amendment, sources disclosed.
It was pointed out that when the specific rule was framed in 1945, India was mainly dependent on the drugs which were imported. Therefore, it might have been prescribed to procure and send such imported drugs for test or analysis, sources said.
However, in the present situation India is producing drugs worth about Rs. 100,000 crores and out which drugs worth Rs. 52,000 crore are meant for the domestic market while the rest is for the exports. But there is no explicit provision to draw the samples of drugs of Indian origin from the retailers.
The Rule 51 specifies the duties of inspectors. As per the existing provisions, it will be the duty of an inspector authorized to inspect premises licensed for the sale of drugs to “inspect (not less than once a year) all establishments licensed for the sale of drugs within the area assigned to him; to satisfy himself that the conditions of the licenses are being observed; and to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder.”
It also gives the authority to the inspector to investigate the complaints, institute prosecution in respect of breaches of the Act, and to maintain record of inspections, among other duties. However, the rule does not specify about his duties with regard to picking up samples from the retail shops.