India’s drug regulator has said that more than 90% of cough syrup manufacturers in the country have been audited following the deaths of 22 children in Madhya Pradesh last year due to contaminated syrups.
Speaking at the 11th Global Pharmaceutical Quality Summit organised by the Indian Pharmaceutical Alliance in Mumbai, Drug Controller General of India Rajeev Singh Raghuvanshi said the crackdown on errant manufacturers is ongoing and inspections continue with the same intensity and purpose.
Since the incident, more than 1,250 manufacturing units have undergone risk-based inspections. Of these, around 1,100 cough syrup makers have been audited, covering over 90% of such manufacturers nationwide.
Raghuvanshi noted that while strengthening enforcement, the regulator is also working to modernise the regulatory framework to make it future-ready. With advancements such as artificial intelligence shifting research from in vitro to in silico models, regulatory science must evolve accordingly.
At present, approvals rely heavily on recommendations from expert committees formed as needed, drawing specialists from various fields. To streamline this process, the regulator plans to create an internal scientific “flexi pool” within the next one to two years.
Around 40% of this pool will comprise contractual or advisory experts rather than permanent staff. These specialists may include microbiologists, biotechnologists, biostatisticians, project management professionals, and other domain experts across the pharmaceutical value chain.
The objective is to deepen subject expertise within the system, speed up approval timelines, and enable the regulator to tap into global expertise whenever required.
