Most failed drug samples from Himachal Pradesh lack active agent

Ambika Sharma

Solan, May 26

Pointing to a worrisome scenario, it has come to light that lack of assay (active ingredient) and failure in disintegration (absorption) tests are the main reasons for drug samples of Himachal pharmaceutical units failing quality tests.

An analysis of monthly alerts issued by the national drug regulator, Central Drugs Standard Control Organisation (CDSCO), revealed that of 76 drug samples from the state declared substandard this year so far, 51 either lacked assay content or failed disintegration tests.

Experts have warned of complications in patients consuming such drugs. A senior scientist at Kasauli-based Central Research Institute said, “Doctors sometimes prescribe a higher dose to a patient when a lower dose fails to act owing to lack of assay or he switches antibiotics. This is detrimental to a patient’s health.”

If the active ingredient content is below 70 per cent for thermolabile products (drugs subject to change in response to heat) and below 5 per cent of the permitted limits for thermo stable products, such drugs are categorised as grossly substandard by the CDSCO.

These are termed as defects of serious nature which affect the quality and arise out of gross negligence or non-conformance to the Good Manufacturing Practice as per the CDSCO guidelines.

Rajesh Gupta, president, Himachal Drug Manufacturers Association, claimed the state was known for quality drugs, but a few black sheep were bringing a bad name to it. He said the storage conditions should also be take into account while drawing samples as it had been found that lack of adherence to the storage conditions also altered the drug quality, for which the manufacturers bore the brunt.

To minimise sample failure, all drug batches should be tested as per the Drugs and Cosmetics Act for disintegration and dissolution before a batch was released into the market, opined Navneet Marwaha, State Drugs Controller.