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Recent measures by CDSCO to remove hazardous products from pharma market


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Recent measures by CDSCO to remove hazardous products from pharma market

CDSCO has taken serious action against companies which were alerted by WHO for suspicious activities and involved in production of hazardous products in the market.

WHO has issued alerts in three cases of syrup products exported from India. Subsequent to the reports, Central Drugs Standard Control Organization (CDSCO) in coordination with State Drug Controllers carried out joint investigations.

Investigations conducted by CDSCO revealed violation of Good Manufacturing Practices (GMP) and State Drugs Controller, Haryana issued show cause notice to M/s Maiden Pharma under Rule 85(2) of the Drugs Rules, 1945 and order has been issued for stopping all the manufacturing activities of M/s Maiden Pharmaceuticals at Sonipat with immediate effect for violation of GMP.

CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at M/s. Marion Biotech Pvt. Ltd., Noida, Uttar Pradesh. Drug samples were drawn from the manufacturing premises under the provisions of Drugs & Cosmetics Act, 1940 for test & analysis. Further, the manufacturing license of the firm has been suspended by the State Licensing Authority, Uttar Pradesh on 09.01.2023. Further, an FIR has been lodged on 02.03.2023 in the concerned police station and three persons have been arrested.

In the case of Marshall Islands & Federated States of Micronesia, CDSCO in coordination with State Drugs Authority, Punjab, conducted a joint investigation at M/s QP Pharmachem Ltd., Punjab. Drug samples drawn from the manufacturing premises under the provisions of Drugs & Cosmetics Act, 1940 for test and Analysis were declared as "Not of Standard Quality". The State Licensing Authority has directed the firm to stop all the manufacturing activities with immediate effect.

Following the suspension of the manufacturing license, all the manufacturing and export activities of the said companies are halted.

Apart from that, CDSCO and Ministry of Health and Family Welfare have amended the Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable. Also, States/ UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.

CDSCO has mandated to ensure efficacy of drugs, that applicants shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.

The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government. And the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

Moreover, the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce & Industry has issued a notification dated 22.05.2023 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 01.06.2023.