India May Ask SL To Relax Bio-Similar Product Imports

February 16, 2015

In what could be a major boost for the Indian pharma industry, India may be able to resolve the issue of import of bio-similar products with Sri Lanka, The Asian Age reported. The Indian health minister J.P. Nadda is likely to take up the matter with the health minister of Sri Lanka in a meeting on Monday.

Earlier, Sri Lanka had imposed a restriction with regard to import of bio-similar products as per which an exporter must be registered and have undergone clinical trials in a select list of developed countries like the USA, UK, EU, Australia, New Zealand, Canada and Japan.

In his meeting on Monday with Sri Lanka’s health minister Rajitha Senaratne, the health minister is likely to pitch for relaxation on import of bio-similar products and that the Indian companies may be provided a level playing field to encourage their participation in the Sri Lankan market, Asian Age report said.

If all goes well, this will come as a big relief for the pharma industry which has been raising the issue as this makes them unqualified under this criterion, resulting in non-participation in bidding for these products in Sri Lanka. Calling the new regulation unfair, the companies have been alleging that this seems to place an unfair preference for MNCs.

“The issue is important for Indian pharma industry and the minister is likely to discuss it with the Sri Lankan health minister. We are hopeful that Sri Lanka will re-examine the issue and address it,” Asian Age said citing sources in the Indian health ministry.
(with inputs from Asian Age)