Drugs Controller General of India (DCGI) needs to work out stringent procedures on drug transportation, storage and methods of quick recall of product

Karnataka drugs control dept seizes stocks of 5 substandard drugs from retail chemists

Saturday, August 29, 2009 08:00 IST
Nandita Vijay, Bangalore

Karnataka drugs control department has seized stocks of 5 different drugs in surprise inspections at the premises of pharmacists and the tests have proved that these products are not of standard quality. These drugs were tested at the drug test lab housed within the state drugs control department.

One of these drugs is Cefpodoxime Proxetil tablets manufactured by Meridian Medicare Ltd located in Himachal Pradesh. The second is Dexamethasone Sodium Phosphate produced by the Karnataka Antibiotics & Pharmaceuticals Limited (KAPL). Trazidim Midazolam Injection is another product manufactured by Health Biotech Ltd in Himachal Pradesh. The fourth is Kexer-D tablets produced by Biocon Healthcare in Uttaranchal and the fifth drug I Diclofam by Akums Drugs & Pharmaceuticals, at Haridwar.

All the drug stocks were seized during random checks. The only way to ensure sale of good quality drugs is through surprise inspections. The manufacturing practices are not upto the mark in many of the small companies outside the state, said Dr. BR Jagashetty, Karnataka drugs controller.

"An important aspect of a substandard drug is that formulations do not contain the labelled quantity of the active therapeutic ingredient. Indian Pharmacopoeia (IP) prescribes the tolerance limits within which the active ingredient should be present. For example, if a tablet of Aspirin is labelled to contain 100mg. of Aspirin, IP may say when determined by the IP method of Assay, it should be within 95 to 105 per cent of labelled quantity and if the tablet tested has lower amounts then such a batch of aspirin tablets will be declared as 'substandard'," said Dr. DB Narayana, managing trustee, Delhi Pharmaceutical Trust.

According to the pharma industry sources, the substandard drugs can be curbed only with rigorous checks carried out at all levels from sourcing of active pharmaceutical ingredients to the supply of the final formulation. This also includes methods of transportation for drugs across the country. There is also need to monitor the outside temperature within the refrigerated trucks and its working condition.

The units located in the excise free zones which are engaged in production of pharmaceuticals are now proving to be the major source of substandard drugs. However, there are stray cases of well-known companies who are also found to produce drugs found to be substandard. These are likely to be either manufactured by third party producers or by some slip-ups during in-house production arising due to lack of monitoring and quality checks at various stages.

There is no ban on marketing of the drugs produced at excise free zones across the country. But it is the responsibility of the state regulator to ensure quality drugs are sold at pharmacy outlets. This is where the need for Good Distribution Practices (GDP) comes into play. While there are Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) enforced, GDP needs to be mandated at the earliest, said Dr. Jagashetty.

Drugs Controller General of India (DCGI) needs to work out stringent procedures on drug transportation, storage and methods of quick recall of products found not-of-standard quality stated Dr. Jagashetty.



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