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Show cause notices issued to 143 pharma firms after inspections

New Delhi: The Central Drugs Standard Control Organisation along with state licensing authorities has conducted risk-based inspections of 162 pharmaceutical firms and issued show cause notices in 143 cases, Union Health Minister Mansukh Mandaviya said on Tuesday.

In a written reply to a question in Rajya Sabha, he said stop production order has been issued in 40 cases, cancellation and suspension of product/section licenses in 66 cases, issuance of warning letter in 21 cases and in one case, an FIR has been lodged and three persons have been arrested as per the provisions of the Drugs Rules, 1945.

He also said that the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry issued a notification on May 22 for amendment in export policy of cough syrups, making it compulsory for cough syrup manufacturers to get certificate of analysis from a government-approved laboratory before exporting their products with effect from June 1.

Accordingly, more than 900 such cough syrup samples have been analysed and Certificate of Analysis (CoA) released as on date, Mandaviya said.

The manufacturing, sale and distribution of drugs in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945.  The regulatory control over the manufacture, sale and distribution of drug in the country is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs) appointed by the respective state governments.

Manufacturers are required to comply with the conditions of Licence granted under the said Act and Rules to manufacture any drugs for sale and distribution in the country, Mandaviya said.

When cases concerning quality or safety of drugs are reported, the matter is taken up with the State Licensing Authority (SLA) in order to take necessary action.

The SLAs are legally empowered to take action of violation of any conditions of such licenses, including prosecution in appropriate court of law, he said. (PTI)

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