The Maiden Pharma case has once again highlighted the loopholes in India’s medicine regulatory system. The World Health Organization’s (WHO) medical product alert of October 3 that four of the Haryana-based companies’ cough syrup brands were found with ‘unacceptable amounts of diethylene glycol and ethylene glycol as contaminants came after health authorities in Gambia linked these syrups to the kidney damage and subseq inuent deaths of children who had been prescribed these syrups.
Regulators in India sprung into damage control mode. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has since suspended the membership of the company to prevent further exports. India’s apex medicine regulator Central Drugs Standard Control Organisation (CDSCO), with state counterparts, conducted its own investigation at the company’s Sonepat plant. Not surprisingly, they detected several discrepancies and violations of good manufacturing processes at the plant. The Haryana government then ordered the company to stop production at the Sonepat plant.
However, this is not the first time that diethylene glycol (DEG) has turned up to unacceptable levels in medicines. Worse, Maiden Pharma has been a habitual offender. So, clearly, the previous raps on the knuckles were not taken seriously enough.
An overhaul of India’s medicine regulatory system, starting with the recently notified “Drugs, Medical Devices and Cosmetics Bill, 2022” will hopefully plug the existing loopholes in pharma manufacturing and compliance to current good manufacturing practices. But this needs to be implemented not just in the manufacturing plants of pharma companies, but also all thirdparty contract manufacturers and ingredient manufacturers.
However, laws are only as good as their enforcement. Industry sources point out that the CDSCO continues to be under-staffed, despite periodic recruitment drives. The current structure seems to lend itself to territorial skirmishes among centre, states and Union Territories (UTs), allowing shady manufacturers to simply move to different states when one state authority wisens up to their dicey manufacturing practices. So, how much longer will it take for our regulators to be allocated the resources to enforce them?
There is no doubt that the pharma sector will always be expected to work to higher regulatory standards than other industries; simply because it is literally a matter of life or death. The complexity of complying to different regulatory practices across geographies, compounded by competition from other nations vying to discredit India’s claim to be the ‘pharmacy to the world,’ has also increased. Scrutiny by overseas regulators like the US FDA as well as agencies like the WHO, will also increase, to ensure that the imperative to procure medicines at an affordable cost is not at the cost of quality.
Awaiting complete details of the outcomes of the investigations being conducted by agencies, both global and national, Dr Viranchi Shah, National President, Indian Drug Manufacturers Association (IDMA), reminds us that “the Indian pharma industry has demonstrated its capabilities of being a reliable supplier of good-quality affordable medicines” and assures “the best support to Indian and international regulators at all times.”
While IPA works closely with global and Indian regulators and is committed to high quality standards, “Indian regulators are seized with the unfortunate incident at Gambia and this area is receiving their high attention,” says Sudarshan Jain, Secretary General, IPA.
Reiterating the IPA’s overall position that “quality is fundamental in healthcare,” he refers to India’s record of consistently supplying quality-assured affordable medicine globally during the unprecedented COVID times. While the country continues to have the highest number of the US FDA-approved plants, Jain refers to the recent additions of Cipla and Dr Reddy’s Laboratories facilities to the the Global Lighthouse Network, considered a benchmark of quality.
While the top pharma companies have their reputations to protect, what do these statements mean to smaller contract manufacturers, who are far from public eye, and, yes, are used by many top pharma companies to cut costs? They are a huge reason for the affordability of medicines, but as has been proved once again, cutting corners on quality leads to higher costs in the long run.
I am sure that many in the sector will echo Nakul Pasricha, President, Authentication Solution Providers’ Association (ASPA) when he hopes that this loss of innocent lives and the risk of damage to reputation of the Indian pharma industry will “spur concrete actions to correct the situation.”
Asserting that the responsibility of safeguarding the reputation of India’s pharma industry “should be shared by regulators and manufacturers,” he reinforces that “the laws must be strengthened to punish offenders and our regulators should get the resources they need to enforce them.”
While the final results of the wider investigation are awaited, experts are now focussing on what steps must be taken to bring the culprits to book and prevent such incidents in future. Industry stakeholders are working to redeem the ‘pharmacy of the world,’ but this calls for an introspection beyond brand-building.
With Gambian authorities updating the death toll to 70 by October end, it is chilling that some stocks of these products are reportedly still untraceable and could be in circulation, thanks to a weak and porous supply chain.
Pasricha thus uses this latest incident to focus attention “towards the serious consequences of falsified medicines in the healthcare and pharma ecosystem.”
And, can patients play watchdog, tracking both regulator and manufacturer? Pasricha suggests that since it’s ultimately patients who suffer due to such incidents, they must be protected via education and empowerment, and the use of authentication solutions like the use of “phygital” authentication and traceability could go a long way towards curbing such incidents. He suggests that acceleration of ongoing regulatory efforts in this regard, such as the iVeda portal for exports and the QR coding initiative for domestic drugs, could bring centralised data verification and a higher level of security.
Unfortunately, past experience shows that after working to contain the crisis, stakeholders hit the snooze button and go back to ‘business as usual.’ Inspite of many workshops on quality conducted by IPA, IDMA and other industry associations, bad apples in the pharma basket continue to exploit the loopholes, endangering lives and the reputation of the entire sector and the country’s hard-won global credentials. What will it take to break this cycle?