The domestic small scale sector drug manufacturers plan to approach the government to bring in legal provisions to give preference exclusively to Indian drug manufacturers while granting manufacturing and marketing license for the drugs coming off-patent in the new WTO regime.

Divulging the details to Pharmabiz, T S Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), a national body of small-scale pharmaceutical manufacturers from various states, said such an initiative from the Indian Government to protect the domestic industry was unlikely to violate the WTO agreement. Unless the Indian Government comes up with such a provision, more than 90 per cent of the Indian drug manufacturers of about 12,000, including the small and medium scale manufacturers and their loan licensees, might be wiped out for ever from business within a few years, it is feared.

"Though Pakistan is a signatory to WTO, that country does not allow Indian formulations to enter their market, though their government have not legislated to do so, to my knowledge. But they allow Indian raw materials to enter their market. Similarly, it is said that Malaysia also encourages and gives preference to their manufacturers. If such governments can take policy decisions to protect their industry, why India cannot do that," asks Jaishankar.

According to the present stipulations, a new drug approval is under DCGI's surveillance for four years, and then any drug maker in the country can manufacture it. With the new WTO regime, this policy becomes irrelevant. Instead, the Department of Health and Family Welfare should come up with a legislation stipulating the Indian drug control mechanism which will give preference to the Indian manufacturers while considering the applications for products coming off patent. It could be for a period of six months to one year or ideally, two years since the date of off patent, and various guidelines with clear-cut provisions like mandatory BE/BA studies could be incorporated to ensure the safety of the molecule. An expert body should be constituted to work out the details, opined Jaishankar.

"The western world ridicules Indian manufacturers as specialists in copy-cat versions. Our products are termed as inferior in many developed countries, though our industry is among the top five drug manufacturing countries in the world. If that is the case, the multinationals can come to India through the Exclusive Marketing Right (EMR) provisions and with new molecules," noted Jaishankar.

He said CIPI was working on a blueprint in this regard and was planning to meet the union health minister Dr. Anbumani Ramdoss with the suggestions.