Pharma Chamber urges action on delayed drug approvals

The National Chamber of Pharmaceutical Manufacturers Sri Lanka (NCPMSL) has raised serious concerns over prolonged delays in the registration of locally manufactured pharmaceutical products, stating that the process often exceeds two years—far longer than timelines recently claimed by the government.

In a letter addressed to Deputy Minister of Health and Mass Media Dr. Hansaka Wijemuni, the Chamber’s President Dr. Lohitha Samarawickrema said that, contrary to a recent public statement that registration timelines have been reduced to 300 days in line with regional standards, ground realities suggest otherwise.   

“The stated timeline does not align with the practical experiences of our member manufacturers,” the letter said, noting that several product files have remained pending for over four years.   

By comparison, countries like India, Pakistan, and Bangladesh register local generics within 3 to 6 months, and new molecules in 6 to 12 months, according to the Chamber.   

Furthermore, The Chamber expressed concern that the slow approval process not only hampers the growth of local pharmaceutical manufacturers but also exacerbates the country’s medicine shortages.   

The letter pointed out that during discussions held more than two months ago with the Minister of Health, 113 critical shortage items were identified and 43 product files were submitted for urgent registration.   

“Registrations for these remain pending with no visible progress,” the letter added.   

The Chamber has also called on the Ministry to review the 43 urgent submissions and the overall backlog, and to consider implementing a fast-track mechanism for pharmaceuticals listed under national shortage categories.