Drop in exports forces Pharmexcil to seek more assistance from Commerce Min.

Pharmaceutical Export Promotion Council (Pharmexcil) has sought from the Commerce Ministry a number of measures including higher assistance for registration of products abroad to tide over the impact of global meltdown, especially in the wake of decline in pharma exports.

Pharma industry has to bear the expenses of audits of their manufacturing site to register their company with the ministry of health in respective countries. This cost is increasing and are borne by the manufacturer. Support from the ministry is required to increase the number of approved sites in India for the growth of generics, the Pharmexcil is learnt to have taken up with the ministry while seeking greater level of assistance.

The Pharmexcil’s committee of administration discussed the issues and set up a panel last month against the backdrop of 9.76 per cent (in dollar terms) decline of pharma exports during April-September 2009 period. The panel headed by Dinesh B Mody reviewed the steps that need to be taken to push the export and corrective measures. After taking suggestions from the members, the panel has now written to the commerce ministry with the suggestions.

New registration regulation require generic products to be bio-equivalent to innovators which adds to the registration cost and some countries require BE studies from approved labs or clinical research organisations in India only. Indian manufacturers have to import innovator’s products from regulated markets to carry out BE studies and comparative dissolution. The cost of these products is high, according to the note on incentives required to arrest the down trend of pharma exports sent to the ministry.

“In some countries, the exporters have to pay annual retention fees for already approved products. Reference and impurity standards are requested by some countries to test our products before registration approvals and tender product approvals. They make request to supply instruments, equipments, columns etc from the manufacturer. For export of APIs to EU countries and Japan, the requirement of WHO GMP certification is getting mandatory. To obtain this, the sites have to be audited by the officials of from the ministry of health there,” the note said.

Department of commerce of late is not accepting claims for reimbursement of expenses incurred by exporters towards registration under the MAI scheme which is older than one year. Most of the small and medium sector exporters were not aware of the scheme and could not avail it. “It is suggested that ministry may grant one-time permission to clear all old claims towards reimbursement of product registration subject to the overall limit of Rs 50 lakh per annum. This permission may be granted for applying upto March 31, 2011,” the note said.

Actual expenditure for plant inspection, audit fees, airfare and hotel for inspectors, product registration, BE studies, registration retention fees, document legalisation fees, and product QA destination etc may be reimbursed, as per the Pharmexcil. At present, nothing of these are reimbursed.

Besides, the Pharmexcil has also urged the ministry to bear the total expenses for market studies with a maximum ceiling of Rs 200 lakhs per study, enhancement in the level of assistance for showrooms and warehouses leased or on rent, increase in assistance for publicity and campaigns, hike in assistance for participation in trade fairs abroad, research and product development, visa charges for pharma professionals, testing inspection agency charges, among other things.

Source : pharmabiz.com