The small scale pharma units in the country are agitated over the state licensing authorities' (SLAs) refusal to renew manufacturing licenses and permission for additional items for non-compliance of Schedule M in these units. The SSIs feel that the SLAs' action in this regard will lead to closure of more units and is against the spirit of the recommendations of the Najma Heptulla committee on Schedule M.

Perturbed over what the SSIs termed the 'victimisation' by the SLAs, the SSIs are seeking the intervention of DCGI Dr Surinder Singh to solve the issue. A delegation of SSIs will soon meet the DCGI to apprise him about the difficulties being faced by the small units due to the apathetic attitude of the SLAs. The SSIs want the DCGI to circulate the Heptulla report to the SLAs with directions to refrain from victimisation of small units.

The committee, which submitted its recommendations to the government recently, had raised concerns over the closure of SSI units due to the Schedule M implementation and had asked the government to proactively reach out to the SSI sector to support them during the transitory phase as they graduate to become Schedule M compliant.

The SSIs are of the view that in the wake of Heptulla committee recommending the government to assist the SSIs in Schedule M implementation, the government should proactively reach out to the SSIs by providing the required funds for Schedule M implementation and also to refrain the SLAs from withholding renewal of licenses and permission for additional items for non-compliance of Schedule M in these units as the issue is still pending with the government.

The SLAs' action is against the recommendations of the Heptulla committee as it will lead to closure of more units. In the report, the regulatory authorities is on record having stated that 80 per cent Schedule M is documentation. But units are being victimised because of lack of 20 per cent element comprising of space, building and machinery. The machineries list has yet to be decided by MSME department and regulatory to enable funding by DOP, a senior industry leader said.

In its report the Heptulla committee said, "The committee takes a very serious view of the instances of closure of small scale units in certain states. The committee takes into cognizance the concerns raised by the small scale manufacturers over the possibility that the proposed amendments were likely to favour the big manufacturers and the MNCs and deny the smaller units the level-playing field even in the domestic market. The committee also notes the significant contribution of the small manufacturers in the annual medicine production."