IPA seeks to regularise 'legacy' drugs

New Delhi: The Indian Pharmaceutical Alliance (IPA) has asked the domestic pharma industry to provide the names of drugs that have been marketed in India for years but not been approved by the national drug regulator, in a bid to get them regularised by the Central Drugs Standard Control Organisation (CDSCO).

These legacy single-molecule products are off-patent small-molecule chemical drugs that continue to be manufactured and marketed owing to stable market demand and long-established safety profiles. Many of these drugs may have approvals from state authorities, but the details are not available in the central registry.

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The examples cited by the IPA, which represents top Indian pharmaceutical companies, include sodium valproate modified-release tablets (300 mg and 500 mg), an anticonvulsant used to treat epilepsy and bipolar disorder. It is included on the National List of Essential Medicines (NLEM) but is not reflected on CDSCO's approved drug list. Carbamazepine tablets (100 mg, 200 mg and 400 mg), also an anticonvulsant used for epilepsy and trigeminal neuralgia, feature on the NLEM and Indian Pharmacopoeia 2010 at a usual strength of 200 mg, but face similar database gaps.

Also missing from the regulator's list are some strengths of lithium carbonate prolonged-release tablets. The drug, a mood stabiliser used mainly to manage bipolar disorder, is marketed in 300 mg, 400 mg and 450 mg strengths but CDSCO's records reflect only the 450 mg strength.

"Many such products have remained in circulation for well over a decade, but documentation confirming their original regulatory approval is often incomplete or missing from the regulator's records," said IPA secretary general Sudarshan Jain.

Regulatory gaps of this kind, where products have been sold for 15-20 years or more without clear central approval, have been a recurring challenge in India's pharmaceutical regulatory landscape, industry insiders said.

"There are drugs which are available in the market-consumed by everyone when needed but they are not approved. The division of licensing authority-state and central regulators-has led to this discrepancy and there's a dire need to get them regularised," said an industry insider.