Mumbai (PB), 21th May, 2014: Concerned over the plight of ASU exporters in the wake of UK drug regulator MHRA’s recent ban on sale of unlicensed herbal products in UK, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has sought union commerce ministry’s intervention to move WTO on this issue. Objecting to the anti-industry stand taken by UK’s regulatory body, the Council strongly condemned the act and stressed that the ban is a clear violation of trade interest, a subject matter that the commerce ministry should bring into the attention of the WTO.
In a huge blow to the ASU manufacturers, through a recent directive, the Medicines and Healthcare products Regulatory Agency (MHRA) banned the sale and use of all herbal medicines without registration or a product licence in Europe, with immediate effect. Though the EU had made registration or licence compulsory for herbal and ayurvedic medicines sold in Europe from April 30, 2014, against the previous deadline of April 30, 2011, this notification from MHRA comes as a huge shock to the industry.
Dr P V Appaji, director general (DG), Pharmexcil who has been strongly advocating for the Ayurveda, Siddha and Unani (ASU) manufacturers, pointed out that since India has a substantial stake in the exports from the herbal products this comes as a huge cause of concern for the government. “We have already set the things in motion and are studying the subject matter very carefully. Considering this move which clearly stands as a trade barrier, we are doing our best to impress upon the commerce ministry to bring this matter to the attention of WTO forum. We have already discussed our views with the ministry and hope that they will, as always, take requisite steps to represent the industry,” Dr Appaji added.
He further added that this move is being strongly objected not only by Indian manufacturers but also by the local suppliers in UK as well, since they fear this ban will lead to price rise and other complications for the patients. It is understood that, the government is also giving serious consideration to provide financial aid or incentives to the exporters to cope with the increasing cost associated with product registration. Another issue that the industry had been grappling with is their failure to comply with the product registration as required by the MHRA, all due to the huge registration fees associated with the same, varying from Rs.8 lakh to Rs.45 lakh.