The All India Chemists and Distributors Federation (AICDF) has complained to the health and pollution control authorities in five states against a leading pharma company and its CFA in Kolkata for violation of drug rules and the executive order of the Drugs Controller General of India (DCGI) regarding recall of expired and NSQ drugs from the market.
The Federation’s allegation goes against the Mumbai based pharma company and its Kolkata CFA, Shyam Shakti Vyapaar Pvt Ltd. The complaint against the company, drafted by its general secretary, Joydeep Sarkar, has been sent to the drugs control offices, pollution control offices and the offices of the health secretaries in Gujarat, Himachal Pradesh, Uttarakhand, Telengana and West Bengal asking reasons for not taking action against the company as per provisions of drugs and cosmetic rules and the bio-medical waste (management and handling) rules, 1998.
AICDF has wanted the governments of five states to initiate action against the pharma company because the company has manufacturing units at Ahmadabad in Gujarat, Solan in Himachal Pradesh, Hardwar in Uttarakhand, Nalgonda in Telengana and statewide business in West Bengal.
According to Joydeep, the CFA of the company is not taking back the expired and damaged medicines from the premises of the wholesalers and from the shops of the retailers. He says that as per Section 65 (17) of the drugs and cosmetics rules, a trader cannot sell or stock expired drugs in his stores. The executive order of the DCGI mandates the manufacturers to withdraw all date expired drugs from wholesalers and retailers.
“According to various acts and rules, a manufacturer is bound to withdraw all expired and damaged contents from the market with the help of associates for disposing them scientifically by following all norms and regulations of the regulatory authorities. He should also arrange proper and proportionate reimbursements to the traders. The company is not following these stipulations but compelling the traders to dump the unused medicines merely for avoiding some financial loss. In other way, the concerned manufacturer is making the traders accountable and liable for all hazards occurring from expired medicines”, he said.
He pointed out that regular disposal of date expired medicines was required for restricting and preventing contamination, toxicity, bio-hazards and the drug resistance of the human being. Shyam Shakti Vyappar Pvt Ltd is also denying taking back expired insulin packs of Novo Nordisk Pvt Limited. He has pointed out that disposal of insulin is necessary for reducing contamination and bio-hazards.
Meanwhile when contacted Bhupen Mehto, the CFA of the company in Kolkata, he responded that the company was taking back all the expired items from the retailers and wholesalers shops, and they were not violating any law.