The December 2003 deadline for implementation of revised Schedule M in pharmaceutical industry was set by the Union health ministry after detailed consultations with the leaders of small drug units and after granting two postponements earlier. Towards the end of 2003 representatives of the small pharmaceutical units approached the ministry once again and managed one more extension up to December 2004.Until a few weeks ago, no one expected there would be yet another extension. But SSIs forced the government to postpone the deadline for implementation of revised Schedule M for six months more. Confederation of Indian Pharmaceutical Industries, the apex body of small drug units have certainly played the key role in managing this latest extension. The regulatory authorities were not in favour of an extension beyond December 2004 and it looks like more of a politically influenced postponement. What is SSIs hoping to achieve by this kind of arm twisting? There is no justification for the government to make a mockery of the implementation of Schedule M just for the sake of a few lumpen elements in the SSI sector. The problem with some of these SSIs is that they are unwilling to incur any expenditure for modernizing their units. Therefore, it would be wrong to assume that all the 10,000 small drug units in the country will ever be able to conform to Schedule M even if the government grants any number of postponements. Let their leaders understand this fact.
Adoption of international standards in drug manufacturing is becoming a necessity in India today with the country's increasing exposure to the export markets. Almost one third of India's pharmaceutical production is being currently exported. Many top Indian companies are exporting 50 percent of their total production to the developed markets. This export growth is only going to move up in the years to come. Now with the expected introduction product patent in the country from 2005, dependence of Indian drug units on contract manufacturing is going to substantially increase. Without contiously upgrading manufacturing facilities, SSIs cannot hope to get this business. Exiting of several large pharmaceutical companies from manufacturing is also going to help medium and small-scale units to increase their business provided they modernise their facilities. Once the need for adopting standard manufacturing norms is accepted by SSIs and sufficient time was granted, they should prepare themselves for the change. If the finance for modernization is the issue, there are various options and schemes available from financial institutions in soft terms. Commercial banks and SIDBI have already come forward with various schemes to help the units. The National SSI Committee of IDMA launched a series of technical seminars and other programmes for the benefit of SSIs in cities like Chennai, Delhi, Calcutta and Ahmedabad. Several SSIs attended these programmes. The government should also organize such seminars on a national level to motivate SSIs to adopt GMP instead of extending the deadline infinitely.