Ghaziabad pharma firm produces spurious polio vaccines, MD held

  • | Saturday | 29th September, 2018

On September 10, the health ministry ordered us to stop vaccines manufactured by us under the universal immunisation programme till further notice. “The company has been supplying oral polio vaccine to ministry of health and family welfare for more than two decades. But the vaccines manufactured in March 2018 still contained the strain. A CDSCO official said samples of oral polio vaccine manufactured by the firm were collected from Mirzapur and Ghazipur districts between September 12 and September 14 over complaints of adulteration.The samples were sent to the Central Drugs Laboratory for testing. The report, received on September 26, stated that the vaccines were adulterated and “not of standard quality” due to the presence of type II polio virus.The official further said that prior to April 24, 2016, polio vaccines were manufactured with three strains of polio – I, II and III.

GHAZIABAD: The managing director of a Ghaziabad-based pharmaceutical company has been arrested for allegedly manufacturing spurious polio vaccines The accused has been identified as SP Garg, who is the managing director of Bio-Med Private Limited, which is located in Kavi Nagar Industrial area.According to a complaint by the Central Drugs Standard Control Organisation (CDSCO), a prohibited antigen was found in the polio vaccines being supplied by the company under the Union ministry of health’s universal immunisation programme. A CDSCO official said samples of oral polio vaccine manufactured by the firm were collected from Mirzapur and Ghazipur districts between September 12 and September 14 over complaints of adulteration.The samples were sent to the Central Drugs Laboratory for testing. The report, received on September 26, stated that the vaccines were adulterated and “not of standard quality” due to the presence of type II polio virus.The official further said that prior to April 24, 2016, polio vaccines were manufactured with three strains of polio – I, II and III. But after the World Health Organisation announced that polio caused by type II virus has been completely eradicated from the world, the health ministry held a meeting on December 18, 2015 and decided that no pharmaceutical unit will manufacture any vaccine having that strain.Along with other firms across the country, Bio-Med was also asked to stop production of this particular vaccine and destroy existing lots. On September 28, 2016, Bio-Med promised to comply with the order. But the vaccines manufactured in March 2018 still contained the strain. The FIR was registered on Thursday.Garg, along with other directors of the company Puneet Garg, Rajendra Prasad Garg, Kavita Garg and Usha Garg, was booked under sections 17 A, 17 B, 27 (A) and 36 AG of the Drugs and Cosmetics Act. He was arrested late on Thursday evening.Talking to TOI, Garg refuted the allegations. “The company has been supplying oral polio vaccine to ministry of health and family welfare for more than two decades. All batches manufactured by us have been found to be of standard quality. On September 10, the health ministry ordered us to stop vaccines manufactured by us under the universal immunisation programme till further notice. Our manufacturing unit was inspected on September 11 by the officials of CDSCO and all our records and stocks were found in order, but still we were issued directives to stop sale of polio vaccine for 20 days with no specific reason,” he said.“We were also told to recall batches manufactured in 2018 and supplied to the ministry, or else our vaccine would be seized for regulatory action,” Garg added.He said he had written a letter to the Union health ministry on September 15 in this regard and sought their intervention.

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