State FDA asks Haffkine Bio to stop production for not complying with GMP norms
The Maharashtra State Food and Drug Administration (FDA) has ordered the state owned Haffkine Biopharmaceutical Corporation Ltd to stop production of drugs except its oral polio vaccine (OPV), due to non compliance of revised Schedule M.
Haffkine, a fully owned Government of Maharashtra company, registered under the companies Act 1956, has to stop its production since last month, due to the stringent action from the state FDA, it is learnt. "We have conducted inspections in the site and found that a considerable amount of work for up gradation is pending. However, the oral polio section was well upgraded and we have allowed them to continue production only on this segment," Amithabh Chandra, commissioner, FDA told Pharmabiz.
Even as the production has been stopped, the authority will provide all assistance to the unit to gain financial support from the concerned departments for further up gradation. Once the facilities are upgraded, the authority will issue consent for restarting the production, for which the entire authority is keen to help the company, as a fellow organization, according to some other sources from FDA.
However, the company sources informed that the upgradation process is on and is expected to complete soon with the support of the state government. They informed that almost all the up gradation works are completed on par with the new requirements and a few more works are pending on technical side, which will be completed soon.
The company has its major share of supply on OPV for immunization of the masses through the central government run pulse polio immunization programme. Apart from a firm hold on OPV manufacturing, the company has a wide spectrum of products in its portfolio including viral vaccines such as poliomyelitis vaccine (oral) I.P, antitoxins and seras including snake antivenin, ant scorpion venom serum, diphtheria antitoxin, tetanus antitoxin, bacterial vaccines like diphtheria tetanus pertussis (DTP) vaccine IP, tetanus toxoid (TT) IP, diph tetanus (DT) vaccine IP, plague vaccine IP etc.
The company was also engaged in manufacturing injectables like adrenaline tartrate IP, respiphylline and atropine sulphate IP and other products including liquid orals, tablets, capsules and antiseptic products. Haffkine Ajantha Pharmaceuticals Ltd, another subsidiary of haffkine have a product range on anti-inflammatory, anti-hypertensive, analgesics and anti-pyretics, anti-spasmodic, antibiotics, anti-diarrhoeal, anti-allergic, anti-fungal, anti-TB drugs and psychiatric drugs.
The upgradation projects in the Haffkine Ajantha Pharma is also on progress and will be completed soon, to offer better services on par with the latest quality norms, added company sources. The subsidiary was launched in 1977, two years after the launching of Haffkine Pharmaceutical Corporation Ltd.