Apex health regulatory agency Central Drugs Standard Control Organisation (CDSCO) has started an exercise to collect information on all drug manufacturing units across India, News18 has learnt. The CDSCO has asked drug regulators across states and Union Territories to compile profiles of around 10,500 manufacturing plants with data on the production capacity, annual turnover, domestic turnover, export turnover, products list and pipeline, along with other essential details such as proprietor name, number of production units, and addresses.
It has also asked for detailed information on holding loan licences, whether the company supplies for government procurement, list of exporting countries and whether the site has a facility for manufacturing sterile products.
Cleanup
The move comes amid India’s massive drive to unearth the problems in drug making after several allegations were raised by health regulators across the globe.
“The latest move is being undertaken to monitor the production of medicines in the country more closely. So far, there is no legitimate database, especially for micro, small and medium industries on who produces what,” a top government official privy to the development told News18.
MSMEs are manufacturing several products but there is no database to understand their production pattern, numbers, sales and clients, he said. The status of plant certification and approvals is also unknown, the official added.
Treat this as ‘most urgent’: DCGI to state, UT officials
“As you are aware there are approximately 10,500 manufacturing units in the country, which are manufacturing different type of dosage forms and APIs,” said the letter issued by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi on September 4, seen by News18. “In this regard, it has been desired to collate and compile the profile of the pharmaceutical plants operating in the country.”
Marked “most urgent”, the letter reminds officials that similar instructions were sent out in July and August. Still, despite reminders, “…only a few firms have submitted the details so far…”
So far, the CDSCO has inspected more than 162 firms and the investigation reports disclose several serious lapses including selling drugs without bills, buying raw materials without invoices, quality compliance issues, and manufacturing fake medicines.
According to government data, there are around 10,500 drug manufacturing units in the country, of which at least 8,500 are in the category of micro, small and medium enterprises (MSMEs). Of these, 2,000 are approved by the World Health Organization and certified as WHO-GMP (Good Manufacturing Practices).
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