For the second time this year, an India-based pharmaceutical company selling eye drops has been asked to recall its products sold in the United States. A US Food and Drug Administration inspection in October showed that Kilitch Healthcare India Ltd’s facility made the eye drops in an unsanitary factory in India where some workers went barefoot and others fabricated test results that gave the appearance of product safety.
Earlier this year, Chennai-based Global Pharma voluntarily recalled all unexpired lots of its eye drops following clusters of infections linked to its usage in at least four states in the US. US regulators sought recall of Global Pharma products citing violations of CGMP, including lack of appropriate microbial testing, formulation issues, and lack of proper controls concerning tamper-evident packaging, a US FDA statement read.
A CDC statement said that adverse outcomes due to a fault in the eye drops included vision loss in 14 patients, surgical removal of eyeballs in four and deaths in four.
The deaths of children in the West African nation of Gambia put the spotlight once again on the lapse in the quality of drug production in certain India-based pharmaceuticals. Around 70 children, below 5 years of age, died in 2022 after taking the over-the-counter medicines. ET reported earlier this year that a presidential task force recommended the West African nation explore taking legal action against the Indian government.
India-based Marion Biotech’s cough syrups have also been linked to the deaths of 65 children in Uzbekistan last year. Since the middle of last year, the World Health Organisation and other organisations have connected the cough syrups manufactured by Marion and three other Indian companies to the deaths of 141 children in Uzbekistan, the Gambia, and Cameroon.
The Indian government in August 2023 found violations related to manufacturing and laboratory practices at Riemann Labs, a company whose cough syrups were linked to children’s deaths in Cameroon.
Yet, faults in certain Indian pharmaceutical companies are not a new phenomenon. Ranbaxy Laboratories was forced to recall its generic version of Lipitor amid fears of the presence of tiny fragments of glass, which led to further revelations and eventual winding up of the company in 2014.
Reports show that action taken by authorities overseas in not limited to small and medium-level pharmaceutical companies, but even big players such as Sun Pharma, Lupin and others.
Delayed action = Lack of action?
The US FDA had paused its inspections of various facilities in India and elsewhere during Covid-19. Following the lifting of COVID-19 restrictions, the US FDA stepped up the heat on multiple Indian pharmaceutical companies detailing unsanitary conditions in manufacturing plants and poorly trained staff; shredded paperwork and under-investigated customer complaints; and evidence of exporting contaminated drugs to the US, news agencies Bloomberg reported earlier this year.
As news reports of deaths linked to cough syrups piled up, India swung into action, even as it denied charges alleged by Gambia.
There are widespread reports of kids in Africa dying because New Delhi-based Maiden Pharmaceuticals allegedly swapped an essential ingredient for a cheaper, yet fatally toxic alternative for its cough syrups.
Maiden’s plant was shut, albeit only temporarily, as Indian regulators concluded that Maiden had not been conducting essential lab tests. The Indian Health Ministry in October 2022 was quick to clarify that these drugs were not authorised to be sold in India, only abroad. Further, India said as per the ‘usual practice’, the onus is on the importing country to test these imported products on quality parameters and satisfy itself.
The World Health Organisation said that the tragic deaths in Gambia were linked to India, and Maiden, to be specific. India’s then-drug controller general VG Somani wrote to WHO on December 13, saying that its statements on the cough syrup deaths manufactured in India caused ‘irreparable damage to India’s supply chain of pharmaceutical products’.
Following reports of these fatal lapses, the government made it mandatory for cough syrup makers to send samples to government-approved laboratories for testing and analysis before exporting them.
Need for action
India’s Health Minister Mansukh Mandaviya in June claimed that India has issued show-cause notices to 71 companies, of these, 18 have been asked to cease their operations.
“We are the pharmacy of the world and we want to assure everyone that we are the ‘quality pharmacy of the world’,” he said. From June 1, India has made tests mandatory for cough syrups before they are exported. Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before it is exported, effective June 1, a Directorate General of Foreign Trade (DGFT) notification said.
India is currently the largest provider of generic drugs globally, supplying over 50 per cent of global demand for various vaccines, about 40 per cent of generic demand in the US and about 25 per cent of all medicines in the UK.
Yet documentation of lapses continues to flow. Analysts say that once the US FDA steps up inspections further, more skeletons are bound to tumble.
“Pace of inspections is still much lower than it was pre-Covid. As they ramp up, he said, the risk of more adverse FDA findings will continue to rise,” news agency Bloomberg quoted Tushar Manudhane, a pharma analyst at Mumbai-brokerage Motilal Oswal Financial Services Ltd as saying.
The FDA informed US lawmakers in 2019 that India had the lowest percentage of acceptable inspection outcomes at drug manufacturing facilities, at 83%. This was lower than China (90 per cent), the US (93 per cent), and the European Union (98 per cent).
(With inputs from agencies)