India has asked pharma companies to complete and obtain a certificate for good manufacturing practices (GMP) over the next 6 to 12 months. Of the 10,500 manufacturers in India, including MSMEs, only 2,000 of them — mainly exporters —have a good manufacturing practice certificate. 

The remaining 8,500 units will have to complete the certification process within 6 months or 12 months beginning August 1. 

The move comes in the backdrop of WHO raising concerns about some of the cough syrups being sold overseas, leading to the death of children across countries such as Gambia, Uzbekistan, Cameroon, Marshall Islands, and Federated States of Micronesia. 

According to Mansukh Mandaviya, Union Minister of Health and Family Welfare, companies, particularly MSMEs, having an annual turnover of less than ₹250 crore will need to complete the certification process within 12 months, while those with an annual turnover of over ₹250 crore, must complete the certification in 6 months.

“Schedule M of the Drugs and Cosmetics Act has been amended and Pharma companies, including MSMEs, will now have to transition to the new regime” he said. Failure will attract suspension of manufacturing activities, withdrawal of licences and financial penalties. 

Good manufacturing practices is mandatory standards which builds and brings quality into product by way of control on materials, methods, machines, processes, personnel and facility. The Schedule M of prescribes requirements for manufacture, control and safety testing, storage, transport of material, written procedures, records, traceability among others.

Major changes being brought in now will include introduction of Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), Qualification and Validation of equipment, change control management, self-inspection and quality audit team, suppliers audit and approval, stability studies, validation of good manufacturing practices related computerized system, specific requirements for manufacturing of hazardous products, biological products, radio-pharmaceutical and phyto-pharmaceuticals.

The good manufacturing practices was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.A government crackdown saw four companies, identified for manufacture of adulterated of cough syrups, stop manufacturing activities. 

“We have inspected 162 units and 14 public testing labs till now. Major issues found are poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material, infrastructural deficiency to avoid cross-contamination, absence of professionally qualified employees, faulty design of manufacturing and testing areas,” a senior Health Ministry official said.