The Ministry of Health and Family Welfare is working on a draft amendment in the Drugs and Cosmetics Rules 1945 to legitimise imports of pharmaceutical products from Bangladesh to India by road. With this, the rule which already has provisions to specific rail routes for drug imports and exports from Bangladesh will allow the companies to conduct trade through the road ways also.

According to the draft notification, published by the middle of August 2007, the rule 43-A in the Drugs and Cosmetics Rules would be added with the words "Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura: in respect of drugs and cosmetics imported by road from Bangladesh".

Currently, the mentioned rule says that no drug shall be imported from Bangladesh into India except through one of the places, namely, "Ranaghat, Bongaon and Mohiassan Railway Stations: In respect of drugs imported by rail across the frontier with Bangladesh". The ministry has added the new provision as per the Drugs and Cosmetics (Amendment) Rules, 2007.

The final notification may come out at any time after 45 days from the date of notification which means any time from the beginning of October according to official sources. However, the officials added that the final notification is yet to be published.

The trade route by road through three states is expected to enhance better business relation with the Bangladesh pharmaceutical market. Nevertheless, the result of the new inclusion would be difficult to predict at this time, as most of the companies prefer to export their products by air, said a central drugs standard control organisation (CDSCO) official from West Bengal.

The industry sources also feel that the impact of notification in imports and exports of drugs in the country is uncertain at present. The law and order situation and the political issues in the states like Assam and Tripura would tempt the companies still to conduct business through air or rail, rather than through roads, they added.

The central government took the step to amend the rule as it has an opinion that it is necessary to make rules without prior consultation with the Drug Technical Advisory Board (DTAB), in the current scenario. However, the central government should consult the DTAB within six months of making the rules.