In a major action, the Food and Drugs Administration (FDA) has canceled the manufacturing license of a Kandivali-based leading pharmaceutical company BDH Industries Ltd., on charges of misbranding paracetamol tablets to export them to Caribbean countries.
“The license was cancelled on October 25, 2016 after a show cause notice was issued and an offense was registered under provisions of sections 17 B(e), 18 (c), 18 (a), 18 (a)(i), 18 (a) (vi) of the Drugs and Cosmetics Act, 1940 against the firm,” Joint Commissioner (Vigilance), Harish Baijal told Afternoon D&C.;
Last year, lndia exported pharmaceutical drugs worth Rs 1,13,000 crore. The Maharashtra’s share is 32 per cent drugs (worth Rs 32,000 crore) in total drug exports from India per annum. “The export of spurious drugs from Maharashtra will certainly harm the economic interests of the country and will also bring a bad name to the pharmaceutical industry of India. Hence this stringent action was taken,” Baijal.
In July 2016, the FDA found that the company had purchased 16 lakh paracetamol (500 mg) tablets worth Rs 2.75 lakhs from M/s Sysmed Laboratories Ltd., Vadodara, and had repacked and relabelled them as 'Metamol' tablets manufactured by it to export Caribbean countries. A consignment of 10 lakh tablets was ready for export, while remaining 6 lakh tablets were being packed.
In April 2015, the company had procured 80 lakh tablets worth Rs 13.75 lakhs from outside companies and had exported them by repackaging and relabelling as 'Metamol' (500 mg) tablets. Also, the company’s production and quality control staff had made the entries about the mixing, granulation, drawing and tablet compression in company’s log book to make it appear that the tablets were manufactured in Mumbai in different batches.
Since the paracetamol tablets are used to cure cold, headache, fever, body pain, etc. they are available at much cheaper rates in India and are also in great demand in Carribean countries. As such this novel idea was adopted by the BDH Industries Limited to make a quick buck.
Moreover, based on FDA’s complaint, the World Health Organisation (WHO) has rejected the company’s request to renew the WHO-GMP certification.
BDH Industries Ltd. has been a leading pharmaceutical drug manufacturing unit for the last 35 years. It has been manufacturing tablets, capsules, injections, sterile ointments and cyto-toxic products. The company has been one of the leading exporters of medicines to several countries.
DID YOU KNOW
Last year lndia exported pharmaceutical drugs worth Rs 1,13,000 crore. Maharashtra accounts for 32 percent of that figure.