- The pandemic showcased to the entire global community how the Indian pharmaceutical industry catapulted in not only living up to the expectations to produce life-saving vaccines for the country but also for the world in general. We are aware, the Indian pharma sector is renowned for producing so many drugs/medicines that are extremely critical for keeping humankind safe and healthy. Most life-threatening diseases and illnesses require administering medicines, and the Indian contribution here is humongous. Yes, the pandemic also exposed the sector’s vulnerabilities when critical Activated Pharmaceutical Ingredients (API) from China were unavailable to enable final production to roll out. Nonetheless, our presence on the global firmament is solid.
PC: Hikal
- However, of late, a few concerns are being raised globally about the quality of the drugs manufactured locally. As reported by the US drug regulator, FDA, recently, following a plant inspection of Chennai-based Global Pharma is a cause for concern. The report lists multiple negative observations of the manufacturing process of eye drops that were exported. The US has now stopped imports of these eye drops. Separately, media reports indicate that independent inspections of the plant by Indian regulators found that relevant quality standards were met. As such, how do we reconcile these reports? Keep aside exports, the critical question is on the rigorousness of the quality evaluation process for domestic consumption.
- This question needs to be answered against the backdrop of local developments. Last week, the Union Government canceled the licenses of 18 pharma companies for manufacturing spurious medicines. It is reported to be part of a larger crackdown in India. India’s regulatory framework to license drug manufacture and quality control is split between the Union and state governments. It’s led to a fragmented regulatory system. Consequently, it provides arbitrage opportunities because the quality of supervision varies across states. The market for medicines, however, is nationwide. Therefore, not all medicines in the market are subject to the same level of rigor in meeting regulatory norms.
PC: McKesson
- Further, in the five years to March 2021, state regulators collectively tested 77,000 to 85,000 samples of drugs. Spurious drugs were 1 – 0.3% and substandard drugs 3-4% of the samples. Of course, it seems reasonable but there are questions about the sampling and therefore quality evaluation. In India, samples for testing are picked from the market. It makes the sampling methodology critical in assessing quality. Quality problems arising out of fragmentation of the regulatory system coupled with underspending can’t be resolved by intermittent crackdowns. And there’s a shortage of inspectors to ensure standards are not compromised. Needless to say, the need of the hour is to have in place a systemic solution sooner than later.
