AICDF urges DoP to act against drug makers for not recalling expired stocks

Mumbai, August, 2017

All India Chemists & Distributors Federation (AICDF) has appealed to department of pharmaceuticals (DoP), CDSCO and pollution control boards to initiate action against a number of drug manufacturers and their carrying & forwarding agents (CFAs) for violating drug rules pertaining to recall of expired and damaged stocks from traders.

Regular disposal of expired medicines was required for preventing contamination, toxicity, bio-hazards and the drug resistance of humans. The companies deliberately denying to do so can be taken to task as per provisions of Drugs and Cosmetic Rules and the Bio-Medical Waste (Management and Handling) Rules, 1998.

The AICDF has written a letter int this regard to under secretary, DoP, SK Jha on July 18. In the letter, the AICDF has named several prominent companies, including multinational companies, which refuse to recall expired and damaged stocks of drugs from the dealers. For this, these companies in their proposal for sale of medicines with the traders mention that they would not withdraw and settle unsold and expired stocks from dealers under any circumstances.  Instead of complying with the provisions of 56(17) of Drugs and Cosmetics Rules regarding return of expired drugs, these companies hold up the clause in the contract and agreement of sale of medicines with the dealers as a mandate and refuse to take back the expired stock.

As per clause 56(17) of Drugs and Cosmetics Rules, no drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its label or in violation of any statement or direction recorded on such label. It further says that any such drug in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks.

The Directorate General of Health Services in response to an RTI filed by AICDF early this year clarified that the direction for disposal of waste is provided under the Schedule M of the Drugs and Cosmetics Rules and is required to be followed by the drug manufacturers.

Joydeep Sarkar, general secretary, AICDF said “Pharmaceutical industry is reluctant to dispose of the expired stocks which the traders intend to return six months after the product's expiry date. The industry's alibis and excuses of 'time-period’ with no basic and legitimate ground for the same, is compelling the traders to destroy and dispose of expired medicines unscientifically for which the manufacturers and their regional CFAs are solely accountable.”

Six months back AICDF had written to DoP seeking action against Eris Lifesciences for not recalling its expired and damaged stock from traders. Nothing has been done in this regard so far.

The dillydallying of the concerned departments like CDSCO, DoP or pollution control board to initiate steps against the alleged manufacturers and/or their CFAs is giving them prolonged indulgence which is further aggravating ‘resistance of drugs’ of humans too as major side effects of expired medicines destroyed unethically, said Sarkar.

It is the responsibility of a manufacturers to recall all expired and damaged stocks from the market with the help of associates for disposing them scientifically in accordance with regulations of the regulatory authorities. They should also provide proper and proportionate reimbursements to the traders, he concluded.

When contacted DG Shah, secretary general of Indian Pharmaceutical Alliance, a representative body of 20 research based pharmaceutical companies in the country said, “The pharmaceutical industry is doing more than its needful for traders post GST. So far I have not come across any instances wherein industry has refused to take back expired and damaged stock from traders. Though it is ideal for traders to return products to manufacturers within six months after it expired, the same can be sent to makers after six months of its expiry date.”

Echoing the view of Shah, Secretary-General of Indian Drug Manufacturers' Association (IDMA) Dara Patel said, “The industry is complying with standard practice to handle expired and damaged products. So far we are not aware of issue pertaining to industry's denial to recall expired and damaged goods.”