The Directorate of Drugs Control, West Bengal has raised a red flag over quality and efficacy of Udiliv 300 tablets and Chymoral Forte tablets manufactured by Abbott Healthcare and Windias Biotech respectively.
According to Swapan Kumar Mondal, director of drugs control, West Bengal, Udiliv 300 tablets bearing batch no UDB 7080, manufacturing date August 2017 and expiry date March 2020 manufactured by Abbott at Baddi in Solan, Himachal Pradesh has been declared as NSQ with only 0.27% W/W of active ingredient by the Government Analyst, SDCRL. Chymoral Forte tablets having batch no WBA 97083, manufacturing date September 2017 and expiry date August 2019 manufactured by Windias Biotech and marketed by Torrent Pharmaceuticals in Dehradun has been declared spurious by SDCRL.
However, both manufacturers declared that they have not manufactured these products. Director of drugs control, West Bengal has taken a cautious approach to ensure that these products do not reach to people. Mondal dashed off a letter to Drugs Control General of India (DCGI) urging him to keep a strict vigil over the above mentioned products and if any of these are traced anywhere the same may be communicated to him.
While no action has been taken against the companies for failing to ensure product quality, drug wholesalers and retailers in the state are facing risk of penalisation once the products are recovered from their possession.
As per Drugs & Cosmetics Act and Rules, when any drug or cosmetic which is misbranded or adulterated is seized from a manufacturer or the person manufacturing the product for sale on his behalf or a distributor, the burden of proving that such drug is ‘genuine’ shall be on them. If they fail to do so, they shall be punished with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than Rs.ten lakh or three times value of the drugs confiscated, whichever is more.
Expressing concern over this, West Bengal based Progressive Chemist & Druggist Association (PCDA) said, “It is not possible for the dealers to understand the integrity and viability of the products at the time of delivery while the manufacturers and CFAs are not honest enough to declare the entire accountability and liabilities if such misconducts at all appear.”
The PCDA has written to Abbott and Torrent seeking ‘certificate of competence’ and/or ‘batch-wise test report’ of their formulations periodically as a safeguard for the dealers from all relevant legal hazards.
Kaushik Saradar, secretary, PCDA said “We are worried with the fate of our dealers where the hazards and legal compulsions can develop on inspection and seizure of such products from licensed premises of the traders who may fail to skip the onus too. We understand that furnishing the batch wise test reports of the competency of the formulations virtually as a stipulated part of the delivery is highly desired as a safeguard of the dealers of any state from all relevant legal hazards.”
Echoing PCDA’s stand, Joydeep Sarkar, general secretary of All India Chemists & Distributors Federation (AICDF) said, “It is not possible for any dealer to verify the quality of the products even purchased directly from the manufacturers. Manufacturers also cannot deny the ‘supply of sub-standard brands/medicines’ in the market because frequently dealers observe ‘sudden circulars for withdrawal of products under certain batches’ from the manufacturers when the goods are almost liquidated or mostly in the retail outlets and hard to call for from those sources. with the statutory notes, manufacturers escaped from their accountability while dealers remained liable and responsible for any mis-occurrence with all legal constraints on them as defined in the respective laws.”
“Even in exported brands Indian companies faced lots of allegations for supplying sub-standard drugs even in African and South-East Asian countries which is truly shameful. AICDF finds it rational and reasonable to demand test report of brands from every manufacturers expecting a constant moral support of the administration towards the manufacturers fraternity in all aspects,” he opined.
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