The Confederation of Indian Pharmaceutical Industry (SSI) has been relentlessly pursuing certain dilutions in the amended Schedule M with the Government for the last nine months. Repeated efforts have been made on several fronts from DCGI to Health Secretary and Health Minister. Several rounds of discussions were held.
The main misconception among the regulators is that CIPI (SSI) is just asking for time which is not at all the case. All that CIPI wants is certain dilutions in the revised schedule M. Instead of addressing the problem and giving an opportunity to have one-to-one discussion to sort out the issues, Government has simply blamed them as if they are merely trying to postpone implementation. Government's point of view is very unfair and total injustice is done to the SSI sector.
Finding a totally indifferent attitude among the regulators towards the cause of SSI, CIPI has asked the Ministry to form a fresh committee to have a re-look at the Schedule M and CIPI have agreed to abide by the committee's report. CIPI even offered to be a part of the committee to bring about a more practical revision of Schedule M and at the same time, bearing in mind stringent regulation with respect to quality.
Both the Health Ministry and the regulators went on telling CIPI that dilutions will be considered. Nevertheless, CIPI found that dilutions have been done only as a cosmetic change more to give an impression that such dilutions are made other than any intention to consider a reasonable and justified dilutions as recommended by CIPI. In fact, Government has not even cared to reply to CIPI's letter justifying as to why they are unable to consider some of the points put forth by CIPI.
All these points make it clear that there is a force working against the interest of over 3,000 SSI units employing over 2,00,000 people, with an investment of nearly Rs. 5,000 crores.
Hon'ble Minister for Health Dr Anbumani Ramadass told CIPI that his heart is with SSI. But, for reasons in the name of quality, he said that he is not able to consider CIPI's request.
CIPI is of the view that originally DCGI had recommended 2 years extension knowing fully well that SSI sector would need at least that much time to comply with the revised Schedule M. However, the then Government headed by NDA blatantly reduced extension by one year; but, informed CIPI that they would definitely consider one more year extension depending upon the situation at the expiry of one year.
The present Government, in all fairness, can give at least one-year extension and in the meantime, can make necessary corrections in the revised Schedule M in consultation with CIPI.
It is heartening to note that all the State Drug Controllers are genuinely concerned about the cause of SSI units. The State Drug Controllers have a better perception and the practical problems of the SSI unit, which they are inspecting and are able to see reason and justification for some of the dilutions as recommended by CIPI. But, the corridors of power in Delhi are feeling it as a prestige issue rather than consider the plight of the Indian rural market which cannot afford even the current price of drugs, leave alone the increased price which is expected in the immediate future.
The only silver line in the cloud seems to be the re-assurance given by the State Drug Controllers that they are not at all keen to close down the SSI industries and will give all possible support and guidance to implement the revised schedule M in a phased manner at a minimal cost.
SSI sector will usher in the New Year carrying the hope that all State Drug Controllers all over India will have the same rational view. Of course, in all fairness, CIPI has not lost hopes, as it was done by the then Health Minister of erstwhile Central Government, the present Hon'ble Health Minister Anbumani Ramadoss will also spring some surprises at favourable to SSI, considering the genuine demands of CIPI for the survival of large number of small scale industries in India.
- (The author is Chairman, Confederation of Indian Pharmaceutical Industries (CIPI))