Ensuring Safe Drugs
The Government has taken strong actions to remove hazardous products from the Market
Following the alerts issued by the World Health Organisation over the dubious quality in three cases of syrup products exported from India, the Central Drugs Standard Control Organization (CDSCO), in coordination with SDC carried out joint investigations.
Based on investigations, which published a violation of Good Manufacturing Practices, the State Drugs Controller in state of Haryana issued a show cause notice to M/s Maiden Pharma under Rule 85(2) of the Drugs Rules, 1945 and the order has been issued for stopping all the manufacturing activities of M/s Maiden Pharmaceuticals at Sonipat.
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 the Marshall Islands & Federated States of Micronesia, CDSCO in coordination with SDA, 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(STA) has noticed the firm to stop all manufacturing activities with immediate effect.
Following the suspension of the manufacturing license, all the manufacturing and export activities of the above-mentioned companies were halted.
According to the Union Minister of State for Health and Family Welfare, Prof. S.P. Baghel, CDSCO and the Ministry of Health and Family Welfare have taken the following measures to confirm the quality of medicines in the country:
1. The Drugs and Cosmetics Act, 1940 was amended under the Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
2. States/ UTs have set up special Courts for trial of offenses under the Drugs and Cosmetics Act for speedy disposal.
3. The number of sanctioned posts in the Central Drugs Standard Control Organization (CDSCO) has significantly increased in the last 10 years.
4. To ensure the efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicants shall submit the result of the bioequivalence study along with the application for a grant of manufacturing license of the oral dosage form of some drugs.
5. The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of a manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of the Central Government and State Government.
6. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients, etc. to the State Licensing Authority before granting of manufacturing license by the Authority.
Moreover, the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce & Industry has published a notice (No. 06/2023) dated 22.05.2023 for act in the export policy of cough syrups, making it compulsory for cough syrup manufacturers to get a certificate of analysis from a government-approved laboratory before exporting their products with effect from 01.06.2023.