It’s like hearing a song in a loop. The same questions come up on data integrity, the Ranbaxy management vows to fix the problem, Indian regulators promise to investigate transgressions, etc.
Last May, when Ranbaxy agreed to pay $500 million to settle criminal and fraud charges against it in the US, the hope was that the ghost of the drug-maker’s Paonta Sahib and Dewas plants were finally put to rest.
But that was not to be, as cGMP or current Good Manufacturing Practices, violations were reported at Ranbaxy’s Mohali plant and more recently at the Toansa facility (both in Punjab). And the import ban on products into the US from these plants followed.
Industry representatives explain the fine print, that the US regulator slams its brakes on companies even if there is a slip-up in documentation or the manufacturing process.
But while the industry and governments can quibble over how stringent the US requirements are, or not, the details from the US Food and Drug Administration’s public documents are disconcerting, even for those familiar with the cultural acceptance of quick-fix solutions and cultural mismatches between developed markets and developing ones such as India.
Over-writing of data, flies in a room and hair embedded on a tablet are just some of the transgressions listed by the US FDA at Ranbaxy’s plants. In another instance, on Wockhardt’s plants – also facing a similar fate of import bans on two of its plants – the FDA inspection found urine spilling out of a drainage. These tantamount to basic hygiene issues, and are not acceptable from companies at the top of the heap in the Indian medicines market. While it is not clear if similar violations have been noticed and punished by local drug inspectors in the past, the repeated occurrence of violations indicate to something being seriously amiss.
Giving an insight on what could go wrong on the manufacturing front, New Jersey-based J Mark Pohl explains: “In normal manufacturing, the factory makes a batch of drugs, and then a laboratory tests the resulting drug to assure it came out OK. If so, it's sold; if not, it's discarded. Discarding an entire batch is expensive.”
“We pay for all the raw materials, and all the labour, and the time to train that labour, and then must throw the entire product down the drain. Compounding the situation, the final laboratory testing is not perfect; it will give an erroneous result. So, one could take a manufacturing batch which has failed quality testing, and simply re-test the same batch, repeatedly, until the laboratory test happens to show an erroneous passing result. Or simply falsify the test records. This minimises cost, but arguably releases for sale of inferior or dangerous product.”
Zero-tolerance It is time for the local regulator and Ranbaxy’s management to set a high threshold for healthcare— medicines, hospitals, doctors, etc.
Though industry representatives may be right in pointing out that the medicines are not banned in the US on quality, the nagging, though, remains –how a short-cut in procedures does not impact final quality.
Nevertheless, there is some comfort in the fact that other countries continue to source from drug plants in India. The Government has to make good manufacturing practices non-negotiable.