- As you are aware, the Indian pharmaceutical industry is considered one of the topmost in the world for not only manufacturing quality drugs at par with any other competitors but also at a much more affordable rate as well. This standing in the global community is built on a tremendous amount of diligence and assiduously cultivated workmanship over the decades. As such, the onus to ensure the reputation sustains perpetually lies squarely with the manufacturers ably guided by the regulators keeping tab on the quality outputs. Anything related to children is sensitive enough need no further elaboration. Thus, having in place stringent measures to ensure no compromise occurs whilst producing drugs assumes paramount importance.
PC: Bio Spectrumasia
- This is where the Indian pharma company appears to have faltered big time leading to the deaths of 66 innocent children in the Gambia recently. The World Health Organisation alert on four cough syrups manufactured and exported by Haryana-based Maiden Pharmaceuticals to the Gambia resulting in deaths calls for an overhaul of drug regulation in India. Shockingly, reports emanating suggest that the company has been repeatedly pulled up by domestic regulators in multiple states, but those strictures added up to little more than a slap on the wrists. We know how penalties without deterrent effect will not nudge offenders to reform, especially in our country where breaking the law is a norm than an exception in the absence of fear of reprisal.
- Needless to mention, this is common sense and now too many children and their families have paid a heavy price. Of course, Indian pharma’s global reputation is once again at risk after the hugely publicized Ranbaxy fiasco. Yes, state drug controllers tasked with licensing and monitoring manufacturing units and quality control are functioning in silos. If a drug fails a quality test in one state, the obvious thing to do is suspend the manufacturing licence in the state where it is located till a clean-up. Disturbingly, Maiden Pharmaceuticals escaped such punishment. Claiming that the two excipients (substances used alongside active ingredients) that WHO termed as contaminants were sourced from third-party suppliers isn’t tenable.
PC: ABBO News
- It is the company manufacturing the drug which is responsible for quality and rules mandating testing of excipients as well. Moreover, one of the excipients caused deaths in Jammu in 2020. Thanks to a series of regulatory failures, a problematic company, and a dangerous contaminant escaped the attention of drug controllers. To make matters worse in the Gambian tragedy, the Haryana drugs controller certified Maiden as compliant with WHO-Good Manufacturing Practices, making it eligible for exporting drugs. But the central regulator is now answerable to WHO for the failures. To ensure we remain globally competitive, a rigorous regulatory regime is needed. The efforts should start forthwith to have one in place.
