Bulk Drug Exporters Contest Mandatory Registration Process

Mumbai, May 20: | Updated: May 21 2003, 05:30am hrs
Fearing serious implications of the mandatory registration of bulk drugs, bulk drugs exporters have requested the government to amend the new drug import policy, which came into effect from January 1, 2003.

It was in August 2001 that the ministry of health and family welfare, through a notification, made registration of importing drugs mandatory with effect from January 1, 2003.

Almost five months afterwards, the domestic drugs and pharmaceutical industry using imported products as raw materials say the move is seriously hampering their activities.

This policy, therefore, needs to be amended so as to allow import of raw materials from unregistered sources, provided such raw material is used for manufacturing finished bulk drug/formulations meant for exports only.

Accordingly, the Basic Chemicals, Pharmaceuticals and Cosmetics Export Promotion Council (Chemexcil), has urged the government to amend the mandatory registration made for importing bulk drugs.

Chemexcil chairman Satish Wagh said: The overall impact of the mandatory registration is negative and therefore, we have requested the government to do away with this.

Mr Wagh added that the mandatory process, apart from costing $1500 per registration, also takes 6-7 months for clearance, delaying the clearance of export consignments.

The international buyers therefore, have shifted their buying activities to competing countries.

In a letter to commerce secretary Deepak Chatterjee, Mr Wagh said: Most of the Chinese companies are not interested in getting their raw materials registered, with the result that raw materials required for manufacturing finished formulations are disappearing from the market and/or are becoming very expensive. Thus, export of formulations from India under advance licences is becoming unviable.

In India, most of the small-scale and medium-scale formulations industry mainly depends on sourcing raw materials/drugs requirements from countries like China and Singapore.

As the lowest cost is from China, local importers prefer China and convert them into formulations - finished bulk drugs and then re-export them to overseas markets.

India produces over 400 bulk drugs, covering a range of therapeutic groups. Drugs and pharmaceuticals imports were around Rs 2,000 crore in 2001-02, whereas exportshave been placed at Rs 9,943 cr in the same period.

Around 20,000 formulations are exported to various countries in Western Europe, Eastern Europe, North America, South America, the Far-East and the Gulf countries.

Mr Wagh said that during the last few years, Indian bulk drug producers and formulators have created vast production capacities, leading to intense competition.

This has resulted in better efficiency, cost reduction, wider distribution, adequate availability and lowest consumer prices of pharma products in the world.