New Delhi: The recent spate of recalls of drugs manufactured in India from the US market raises critical questions for Indian drug manufacturers and drug regulatory authorities: Are Indian lives cheaper than those of Americans? Are Indian drug standards and regulatory oversight on par with international norms?
Consider this. Sun Pharma recalled over 96,000 bottles of Liothyronine Sodium tablets from the US last week due to impurity concerns raised by the US regulator Food and Drugs Administration (FDA). Lupin recalled an unspecified quantity of penicillamine tablets, manufactured at its Nagpur facility, for “failed dissolution specifications”
Both recalls were classified as Class II by the USFDA, which is designated to a product with the “potential to cause a temporary or serious health problem”
Earlier in November, Glenmark Pharmaceuticals recalled 37,200 bottles of indomethacin capsules. Sun Pharma also recalled 2,016 bottles of bupropion hydrochloride extended-release tablets. Glenmark had mislabelled indomethacin capsules as Naproxen, another arthritis drug, while Sun Pharma’s product was a Class II recall due to “failed dissolution specifications”.
On November 15, Mumbai-based Kilitech Healthcare recalled all batches of 25 different formulations of eye drops from the US market, after a US FDA inspection flagged “unsanitary conditions” at the firm’s manufacturing plant. One could go on.
According to statistics compiled by US law firm Lightfoot Law, which represents patients in injury cases against drug manufacturers, between 2012 and 2021, leading Indian pharma company Dr Reddy’s had 98 recalls, Lupin had 71 recalls, Torrent had 77, Zydus had 44 and Aurobindo 34, just to name a few of the more prominent Indian pharma cos in that exhaustive list. In fact, FDA recalls totalled 12,787 between 2012 and 2021 (April-June).
In sharp contrast, there was next to no such recall in the Indian market of the same drugs manufactured by these companies.
India’s $50 billion pharmaceuticals sector – the third largest globally– is also the world’s biggest supplier of generic drugs. sector, which is also the biggest supplier of drugs to the US market, has repeatedly failed to meet the quality standards of the FDA.
An academic study by Shray Bablani and Manthan Janodia of the Manipal College of Pharmaceutical Sciences of FDA warning letters issued to Indian manufacturers between January 1, 2005, and December 31, 2018, found that “across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased”.
“Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the current good manufacturing practices of FDA. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved,” the study said.
While the US has different standards from India, the variation is not so wide that drugs that fail the test in the US meet Indian standards. India’s drug standards are generally on par with global norms, but the gap lies in regulatory enforcement and oversight.
Unlike the US which has a law mandating recall of substandard drugs, India has no such law, even though a proposal to create such legislation was mooted in 1976. That year, a meeting of the Drugs Consultative Committee, which includes state drug controllers, the national drug regulator, the Central Drug Standard Control Organisation (CDSCO) and the ministry of health, discussed the need for a national law on drug recalls as it was found that drugs banned in one state were on sale in another.
This failed to materialise despite multiple prompting points to the lobbying power of the pharma industry. There is also a Centre-state divide, with states resisting greater centralisation of powers. There is also little interaction and information exchanged between the various central and state authorities. The health ministry simply lacks the expertise in complex drug regulatory issues.
There also appears to be a mistaken belief in some circles that having mandatory recalls will harm India’s pharma exports. Nothing could be further from the truth. Recent controversies like the contaminated Indian cough syrup being linked to child deaths in Gambia and Uzbekistan have shown that in the era of social media, such reports of substandard drugs can cause more harm than a regulatory process.
If India wants to reach the next mile in the global pharmaceutical industry and move from being a supplier of cheap generics to more complex drugs and innovations, there must be global acceptance of its quality control and regulatory processes. Without this, the “Made in India’ tag will become a drag in the highly competitive global pharmaceutical market.