The Karnataka drugs controller Dr. BR Jagashetty has recommended the strict and uniform implementation of Good Distribution Practices (GDP) in the country to check the prevalence of substandard drugs occurring due to the lack of proper storage conditions in the lakhs of pharmacy outlets in the length and breadth of the country. Dr Jagashetty will soon send a proposal in this regard to the Drugs Control General of India (DCGI).

There is an urgent need for the immediate implementation of Good Distribution Practices in the country. This will bring in a close monitoring of the refrigerated vans carrying the drugs across the country. Although the cold chain could be one reason in the deterioration of the active ingredients present in the drug, the department has no authority to inspect this. There should be clear-cut guidelines on how to transport, storage and ensure faster recovery of drugs in transit if suspected to be substandard at any point of inspection, Dr. BR Jagashetty told Pharmabiz

In a bid to check the presence of substandard drugs in the pharmacy outlets, inspectors pick up the samples at random. When the medicines are found to be not of standard quality, pharma companies attribute it to the poor storage practices prevailing at the pharmacy outlets. But in Karnataka, pharmacy outlets are not granted a license in the absence of a basic refrigerator to store drugs.

While the pharma industry opines that regulators also need to look at the storage practices at pharmacy outlets, Dr, Jagashetty begs to differ. According to him, the onus of storage lies with the pharma industry. "It is their responsibility to educate the chemist, ensure that refrigerators are operational during power cuts and breakdowns to maintain the quality of the drug," he added.

A drug is termed as 'substandard' when it does not contain the labelled quantity of the active therapeutic ingredient (ATI). Indian Pharmacopoeia (IP) prescribes the tolerance limits within which the active ingredient should be present.

There are a number of reasons for drugs to be substandard. One could be intentional addition of low amounts of ATI by unscrupulous manufacturers without adhering to good production practices, use of poor quality excipients and bad packaging. One another important factor is the improper storage conditions from the manufacturing plant to the retail shelf, said Dr. DB Narayana, managing trustee, Delhi Pharmaceutical Trust.

This is where Delhi Pharmaceutical Trust (DPT) has published 'Good Storage Practices -Guidelines' for Pharmaceuticals for retail and cold chain transportation. IP 2007 utilized DPT's recommendation and insists to label the storage environment required for the drugs, he added.

According to Kaushik Desai, CEO of Global Pharmatech, deterioration of active ingredients takes place with poor storage conditions. The vagaries in weather result in the destabilizing many of the chemical contents in drugs. For instance, during the scorching summers in parts of north power cuts are frequent, medicines are bound to lose the strength. The drug will carry label instructions to be stored in cool and dry conditions, but chemists are unable to do so.

"There is no data on the exact storage conditions at the C&F agents, godowns and wholesale premises. Some data generated by Delhi Pharmaceutical Trust (DPT) indicate the high prevalence of poor storage. Drugs like aspirin, atenolol, anti-bacterials/antibiotics-like ampicillin, cloxacillin, anti-diabetics (insulin) and vaccines are inherently known to degrade faster, if exposed to heat, moisture and light, stated Dr. Narayana.