India tightens export rules for medicines to check wide misuse as narcotics in overseas markets
The development comes against the backdrop of unapproved Indian-made drugs being exported to countries in Africa and being rerouted to other destinations.
New Delhi: The Centre has tightened the rules for exports to check the wide abuse of medicines manufactured in India, three officials aware of the matter said. The guidelines are applicable to unapproved and approved new drugs for exports purpose only and manufacturers have to comply with the legal procedures, two officials aware of the matter said.
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With some of these drugs being used in overseas markets as narcotics, the Central Drugs Standard Control Organization (CDSCO) has introduced a two-step verification for the manufacturer that will be checked at Indian ports.
In addition, the apex drug regulator has made it mandatory for manufacturers to obtain regulatory approval from the importing country for medicines classed as narcotic drugs and psychotropic substances (NDPS).
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The development comes against the backdrop of unapproved Indian-made drugs being exported to countries in Africa and being rerouted to other destinations.
Under the new rules, a manufacturer has to first obtain a no-objection certificate (NOC) from the Central Licensing Authority. Once approved, the consignment and all related documents will be verified at the port before shipment.
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Earlier, there was no detailed verification of the manufacturer at Indian ports. The manufacturers will have to submit the details of quality of products, manufacturer’s name, name of the exporting country and details of the buyer.
These regulations have been made under the relevant provisions of the Drugs and Cosmetics Act, 1940 and Drug Rule, 1945. A guidance document for manufacturers seen by Mint has been issued by CDSCO.
In case of unapproved FDC (fixed dose combination), unapproved NDPS and banned drugs in India, the manufacturer is required to mandatorily get the approval of the importing country's regulator.
“This entire exercise will ensure that only approved consignment will be shipped from India to the destination country. This is one way to have greater vigilance for exports of unapproved and approved new drugs from India," said one of the officials cited above.
Step two involves the procedure for release of consignment at the Indian port office.
“New guidelines have been issued and these requirements were not in place and divided in two steps. The first thing is online documentation to get the NOC and the second step is physical verification at the ports. This will have uniformity and create the system of traceability all throughout the process," said the second official.
As per the department of pharmaceuticals, the Indian pharmaceutical industry is worth approximately $50 billion with over $25 billion of the value coming from exports. About 20% of the global exports in generic drugs are met by India. The country has 10,000 pharmaceutical companies, out of which 2,000 are MSME drug firms.
Queries sent to the health ministry spokesperson remained unanswered.
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