In an effort to create more regulatory capacity, the Drugs Controller General of India (DCGI) is looking to streamline certain export procedures, including shifting from a customer-centric system of certification to a quantity-based approach.
The present system involves giving NOCs (no objection certificates) for the export of unapproved drugs to individual customers / companies, explained the DCGI Dr Rajeev Raghuvanshi. The plan is to give an NOC for a larger quantity, leaving it to the exporter to file the relevant details with the authorities, he said, adding that the steamlining would free up officers from routine administration to doing more value-added tasks. (These medicines would need prior approvals from the importing country.)
This streamlining would bring down the number of NOCs from about 15,000 to 5000, Raghuvanshi told media representatives. The DCGI is also looking to halve the number of test license requirement for products used in analysis etc, he added.
Presently there are about 2000 regulators, between Centre and State, to regulate the vast universe of 10,000 manufacturing plants, 10 lakh sales units and about 4,000 medical device-making units, he said, laying out the case for more efficient regulatory work. The effort was to be light on regulation and heavy on execution, he added.
Quality Summit
The DCGI was participating in a Quality Summit organised by the Indian Pharmaceutical Alliance, a platform for large domestic drugmakers in the country.
And the export-related measures come against the backdrop of reports of alleged abuse of a combination drug from Indian drugmaker Aveo Pharma, in Western African Countries. While details of this incident are being further examined, he said, about 77 NOCs had been given on this product.
The regulatory system was struggling to manage two extremes – the best and worst in the world, he said, urging large drugmakers to handhold smaller drugmakers to up their quality standards. About 60 percent of the medicines were being produced by small and medium enterprises for larger companies, he said, calling for greater responsibility to ensure good practices. He also urged industry to call out the bad actors among them, echoing a call made recently by Commerce Minister Piyush Goyal, at another pharma industry gathering.
Other policy measures in the pipeline, he said, included guidelines for biosimilar products and for cell and gene therapies. Several companies in India have plunged into making these therapies, with a couple of them having got regulatory approvals already.
The drug regulator also said a digital regulatory database was in the works, an estimated ₹100 crore project, expected to be operation in a couple of years.