Express Pharma

Dr Dinesh Dua, Chairman, Pharmexcil; Chairman, Entrepreneurship & Start Ups, CII North India; CEO & Director, Nectar Lifesciences

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Incorporation of stability testing by the Drug Controller General of India DCG(I) for approval of drugs in India has actually raised the bar of standard for the quality of drugs being launched in the Indian market at par with the other developed nations and organisations (like ICH).

Advantages of stability data generation

  • It gives assurance that our products will be stable throughout the shelf life.
  • It helps in studying the root cause of failure of any batch out in the market.
  • Products which are charged annually on stability provide further assurance of the continuous quality of the product.
  • It helps in proposing extended shelf life for the products.

Some might feel that stability data for products that have already been in the market for decades should not be asked for by the regulatory agencies. However, we have to understand that different companies may have different formulations and recipes for the same product which may impart different stability behaviour to the product and therefore, it becomes imperative that each product should be tested for stability.

We should not look at this requirement as mere a regulatory obligation; but we should look at it as our moral and ethical responsibility to ensure that the products that we offer for our fellow human beings are efficacious as well as stable throughout their intended shelf life.

It has definitely increased the cost for drug products. However, nothing is costlier or precious than human life and in the long run, it will only yield profits as the ample knowledge gained from stability studies will help us curtail the number of undesired product recalls. In my considered opinion, stability testing is an important part of drug development and approval process as it determines the ability of the pharmaceutical dosage form to maintain the physical, chemical, therapeutic and microbial properties during storage and usage by the patient.

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