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Pharma industry, trade concerned over issue of growing expired drugs with no set rules
Nandita Vijay, Bengaluru | Monday, August 7, 2017, 08:00 Hrs  [IST]

Pharma industry and trade are in a dilemma how to handle the issue of increasing stocks of date expired drugs in the absence of a dedicated set of rules for the same. Although there have been recommendations to clear date expired drugs at the earliest, these medicines continue to get accumulated in companies or at trade outlets.

Date expired drugs are now like a spanner in the works. The trade is not fully reimbursed for the unsold and date expired drugs by the manufacturer. Furthermore, the obligation of its safe disposal is on the manufacturer. States like Karnataka adhere to the State Pollution Control Board norms for its disposal. The GST regime calls to maintain records of batch wise details of sales. Here stocks of date expired medicines have thrown a wrench in the works.

According to Dr. BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka state drugs controller, Union government should frame a set of dedicated rules on date expired return/disposal from pharmacy outlets to the concerned manufacturers. The manufacturers need to discard and dispose them off as per the directions of Ministry of Environment’s Pollution Control Boards.

As on today Rule 65 (17) states that such date expired drugs should not be sold. The Drugs & Cosmetics Act has no exclusive provisions for return or disposal of the same. Usually this is an understanding between the company and the trade. Therefore, there is need to frame regulations for the same. The pharma manufacturers should be made liable for the same. The companies have to return huge sums of money for the remaining stocks of date expired drugs and also look at ways to discard them in the right manner, he added.

This is where the Trace & Track regulations come to play. Then it will be far easier to lay hands on the return and disposal of date expired drugs, noted Dr Jagashetty.

From an industry perspective, Harish K Jain, secretary, Karnataka Drugs & Pharmaceutical Manufacturers Association, said, “Date expired drugs is a serious issue and one has to live with it. There is no escape. Currently, quantity of date expired drugs is estimated to be around 1.5% to 2% of the total drugs in the market. The need of the hour is to ensure that these drugs are not sold to patients because it lacks safety, efficacy due to reduction of potency along with dissolution/disintegration failure. There is need for 100% voluntary compliance. Equally important is security and disposal of these drugs according to pollution control norms at authorized centres with proper records maintained which is the least companies need to comply, he added.

Many a time date expired drugs result in a conflict between trade and companies. Progressive companies have adopted two pronged strategy. First is to close inventory monitoring & management at the distribution level. Second, to adequately compensate distribution channels for the loss, noted Jain.

Companies generally factor the cost of this compensation while fixing the prices. There is also need for companies to encourage R&D to increase the shelf life to reduce expiry dated drugs. This could be as simple as change of packaging from PVC Film to PVC/PVDC Film, said Jain.

Representing the pharmacy trade, Ravindra Kumar MJ, Member, Karnataka Chemists & Druggists Association, said it is the manufacturers or C&F Agents’ basic responsibility to ensure date expired drugs are being taken back and disposed in the right manner and this is being practiced in Karnataka.

Comments

Bharathkumar reddy Jan 9, 2018 5:01 PM
Hi All,

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