Govt prohibited manufacture, distribution for human use of 14 FDCs: Health Minister
Union Minister of State for Health and Family Welfare Bharati Pravin Pawar on Tuesday said that the government has prohibited the manufacture for sale, sale or distribution for human use of 14 fixed dose combinations (FDCs) including various cough syrup formulations on basis of recommendation of expert committee.
The Minister said this in response to a query in Rajya Sabha on whether it is a fact that government has banned 14 cough syrups citing risk to humans.
“The WHO (World Health Organisation) has issued alerts and asked various information in four 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,” she said in response to a another question whether these cough syrups were of substandard quality due to which nearly 300 people died worldwide as stated by WHO in its investigation.
In case of Cameroon, the Minister said that a joint inspection was conducted by CDSCO, Sub-Zone Indore with SLA, Madhya Pradesh at M/s Riemann Labs., Indore and based on the findings the State Drugs Controller MP has directed the firm to stop the manufacturing activities.
She said that the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry had issued a notification dated 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.
She said that in the case of Gambia, joint investigation was undertaken by CDSCO and State Drug Controller, Haryana.
She said that based on investigations conducted, which revealed violation of Good Manufacturing Practices (GMP), 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 at Sonipat with immediate effect for violation of GMP.
She said that in case of Uzbekistan, CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at M/s Marion Biotech Pvt Ltd., Noida, Uttar Pradesh.
She said that the drug samples were drawn from the manufacturing premises under the provisions of Drugs and Cosmetics Act, 1940 for test and analysis. Further, manufacturing license of the firm has been suspended by State Licensing Authority.
