The SME Pharma Industries Confederation (SPIC), representing thousands of small pharma manufacturers spread across the country, has asked drug controller general of India (DCGI) Dr Surinder Singh to include the apex body part of the ongoing deliberations on amendment to definitions of spurious, misbranded and adulterated drugs in the Drugs and Cosmetics Act 1940, as was mooted by the union commerce ministry.

Even though the DCGI office has already started the process of deliberations in this regard, the SSIs that estimated to contribute 40 per cent to local production and export, making them the single largest stakeholders and backbone of Rs 90,000 crore Indian pharma industry, were kept out of deliberations.

When the SSIs took cudgels against the DCGI decision to exclude them from deliberations, the DCGI asked the SPIC to provide written opinion or suggestions on the issue which was rejected by the SPIC on the plea that it will not serve any meaningful purpose.

Taking exceptions to the DCGI's refusal to make them part of the deliberations, SPIC secretary general Jagdeep Singh said that no purpose is served by submission of opinion or suggestions. "We should be brought at par with others who are part of the deliberations as SMEs are single largest segment contributing over 40 per cent to the total drug production and the changes always have a major impact on SMEs," Singh said.

Singh further said that the SSIs serious concern emanates from past experience when Schedule M and MRP-based excise collection were levied in 2005 - both without consultation of SMEs who became the worst sufferers and many units had to be closed down. Deliberations serve a purpose which is way beyond written opinion or suggestions. There is every reason why SMEs merit inclusion in deliberations of meetings, he said.