A close interaction between the pharmaceutical machinery manufacturers and the drug manufacturers is inevitable while supplying machines in compliance with the revised GMP requirement. Since a better understanding of the exact requirement of the drug maker would only help the machinery sector to serve the user industry, it has become more important in the present scenario, said S.S. Lamba, senior general manager (works), Lupin Ltd.

The executives and other senior officials involved in the production within the drug industry would be more knowledgeable about the technology changes happening in the national international scenario. Hence, they would be in a position to educate the machinery manufacturers about the US FDA requirements, he said. In the US, companies like Eli Lilly and Bristol Myers Squibb (BMS) have formed joint ventures with machinery manufacturers helping them to tailor make the products as per the latest FDA requirement.

Addressing a gathering of allied industry at a seminar organized by the Indian Pharmaceutical Machinery Manufacturers' Association (IPMMA), Lamba highlighted the need for the upgradation of manufacturing practices according revised Schedule M of the Drugs & Cosmetics Act and also to create awareness of the internationally recommended "WHO" guidelines.

Revised GMP is the new challenge to be faced by the Indian industry to harmonize the production of drugs and pharmaceuticals in the level of internationally accepted production practices. It prescribes in detail the mandatory requirements of premises, plant and equipment for the manufacture of drugs and pharmaceuticals. The Central Drug Standard Control Organisation (CDSCO) has earmarked December 31, 2003, as the deadline for the industry compliance of the revised Schedule M requirement.

IPMMA is currently the only organisation in the country representing pharma machi-nery manufacturing sector exclusively having about 80 members. The country is estimated to have about 550 pharma machinery manufacturers. "The sector was highly unorganized with a large number of small scale manufacturers. IPMMA's objective now is to hold seminars across the country and educate small manufacturers about improving the quality of their machines at par with international requirements," said Bhavna Shah, president IPMMA.

"Currently, the Indian industry is at a transition phase in its Schedule M implementation. We are more aligned towards the European Schedule M requirement compared to the US requirement," said Lamba. Although the GMP guidelines are available, the real question lies in how these guidelines are going to be interpreted by the machinery manufacturer, he said. And another big threat the machinery manufacturers can anticipate now is the imminent reduction in the number of pharma units in the country. There are about 17,000 drug manufacturing units in the country, a majority of whom are going to be eliminated on account of the ongoing globalisation pressure. "By 2007, the number of manufacturers is estimated to be reduced to 1,500," he said.