The tragic images of 22 children dead last year in Madhya Pradesh due to consumption of contaminated cough syrups has apparently set in motion efforts to rein in errant manufacturers. This, according to India’s drug regulator, is underway even as the regulatory lattice is being strengthened with an eye on future-readiness. Speaking to journalists at the 11th Global Pharmaceutical Quality Summit, organised by the Indian Pharmaceutical Alliance in Mumbai on Monday, February 23, Rajeev Singh Raghuvanshi, the Drug Controller General of India, says so far, since then, over 1,250 manufacturing sites have been audited under risk-based inspections. In addition, around 1,100 cough syrup manufacturers have been audited. This covers over 90 percent of cough syrup manufacturers in the country. This, he says, underlining the point that risk-based inspections are still continuing with the same rigor, same motivation and same purpose.
On the larger subject of deregulation and the strengthening of regulatory science, especially in an era where, thanks to artificial intelligence, the focus is shifting from in vitro to in silico and therefore the need to be future-ready, he explains the changes contemplated. Currently, he says, we are dependent on expert committees’ recommendations, and this is very flexible. So depending on the need, we collect experts from different places, and form a committee, and then they recommend and evaluate.
In a bit to improve on this and shift this internally in next year or two, he says, “we are creating a pool of internal scientific cadre, this will be a dedicated Flexi pool. Also, about 40% of this number would not be a permanent staff. That will be a flexible component, which we will be either appointing on taking on contract.” It could be an advisor or a scientist with expertise across all the relevant branches . The expert, he explains, could be in microbiology, biotechnologist, biostatisticians, experts in project management or in any domain that impacts the value chain.
The ultimate aim being to enhance subject expertise and reduce time taken for granting approvals. The format will be flexible enough to allow tapping of any expert globally too.