The small scale drug units have taken strong objections to the union health ministry's reply to the Najma Heptullah committee's questions on implementation of Schedule M in the country. The Heptulla committee, which was constituted more than two years ago to study the impact of the implementation of revised Schedule M on small scale pharma units in the country, tabled its recommendations in the just concluded session of Parliament.

Finding serious faults in the ministry's reply to the committee, the SME Pharma Industries Confederation (SPIC), a confederation mostly consisting of small companies, has shot off a letter to the department of pharmaceuticals pointing out the factual mistakes in the ministry's reply to the committee.

To a query whether the Schedule M was detrimental to the SSIs and will lead to unemployment, the ministry had replied that the Schedule M was not detrimental to the SSIs, and a large number of SSIs have already complied and the rest are doing so. Strongly contesting the ministry's reply, SPIC has asked, 'if that be so then why have units been closed down and why PTUF is being prepared four years after implementation and why is NIPER setting up Sample SSI Unit (which will take two years to complete) to guide SSI?'

To another query if the apprehensions of the SSI units justified that Schedule M requires huge investment in equipment, increase in area, large amount of documentation and validation that require staff increase, the ministry had replied that 80 per cent norms do not require investment and certain provisions have already been relaxed.

Contesting the ministry's reply, SPIC said that the ministry reply is misleading because the issue is investment and not effort. Secondly, 80 per cent can be complied by SSI only after 20 per cent is complied. Upgradation of each section could cost upto Rs 1 crore. Additionally, equipments like FTIR, TOC, Particle Counter can cost a company more than Rs 50 lakh which an SSI cannot afford.

Schedule M mandates bio-burden free water supply to the unit. This alone costs about Rs 10 lakh. This is exactly what substantiates our contention that standards are multinational set. Drinking water standards were never set because multinationals were not in the business of water supply. In any case, government is responsible for supply of bio-burden free water. Cluster approach advocated for industry in this report applies to drinking water but quality remains poor.

Secondly, no SSI can maintain documents mandated which have been made to sound so simple. At least three B Pharm Graduates are required for documentation alone - which is cost prohibitive. SSIs generally work under owner supervision. Mere making of record cannot guarantee anything. The record making needs to be cut down.

The SPIC has found factual errors in several of the ministry's replies to the committee.