The Central Drugs Standard Control Organisation in coordination with state authorities initiated action against pharma companies following reports of deaths and injuries due to their substandard drugs in the Gambia and Uzbekistan, the government informed Lok Sabha on Friday. The Directorate General of Foreign Trade has issued a notification on May 22 this year for amendment in the export policy of cough syrups, making it compulsory for manufacturers to get certificate of analysis from a government-approved laboratory before exporting their products with effect from June 1, Minister of State for Health Bharati Pravin Pawar said in a written reply.
Responding to a question, Pawar said that subsequent to reports from Sri Lanka, Gambia and Uzbekistan, the CDSCO in coordination with state drug controllers carried out joint investigations at the manufacturing units of the cough syrups and drugs in question.
After deaths of children were reported in the Gambia, the CDSCO in coordination with the Haryana state drug controller carried out an investigation at the manufacturing unit of Maiden Pharmaceuticals Limited to ascertain the facts, Pawar said.
These samples were found to be negative for both diethylene glycol and ethylene glycol.
“Based on investigations conducted which revealed violation of good manufacturing practices (GMP), state drugs controller, Haryana issued show cause notice to Maiden Pharma under Rule 85(2) of the Drugs Rules, 1945 and order has been issued for stopping all the manufacturing activities of Maiden Pharmaceuticals at Sonipat with immediate effect,” Pawar said.
A joint investigation was also carried out at Marion Biotech Pvt. Ltd. in Noida to ascertain the facts that allegedly led to the death of children in Uzbekistan, she said in her written reply.
Drug samples were drawn from the manufacturing premises under the provisions of Drugs and Cosmetics Act, 1940 for test and analysis.
Further, the manufacturing licence of the firm has been suspended by the Uttar Pradesh State Licensing Authority on January 9 this year.
The RDTL, Chandigarh, has forwarded the test reports of 30 drug samples so far, wherein 24 samples of drugs/raw material were declared as “not of standard quality”.
Out of these 24 samples declared as “not of standard quality”, 22 samples fall under the category of adulterated/spurious under sections 17A and 17B of the Drugs and Cosmetics Act. An FIR was lodged on March 2 this year and three persons were arrested, the minister said.
Following a complaint received regarding Prednisolone eye drop, drug samples were drawn from the premises of Indiana Opthalmics LLP in Gujarat for test and analysis, Pawar stated.
Further, the Gujarat state drugs controller issued show cause notice to the firm on June 2 this year.
In the matter of complaint received regarding Propofol injection, drug samples were drawn from the premises of SP Accure Lab Pvt Ltd in Hyderabad. Further, the state drugs controller of Telangana has cancelled the product permission of Propofol injection, the minister added.
