The Supreme Court has given a stay order on the Uttaranchal High Court ruling, questioning the need for WHO-GMP certificate for participating in the government tenders for local medicine purchases.
The Apex Court is to hear the appeal on November 10. The Uttaranchal HC verdict was one among the four similar verdicts given by High Courts of Andhra Pradesh, Uttar Pradesh and J&K in the recent past.
The small scale drug sector, whose sustenance is often based on the supply of medicines to government hospitals and medical institutions, has once again turned silent with the fresh development. The HC verdicts in support of the SSI stand and the recent Central Government move to instruct all medical establishments coming under the Union Health Ministry to avoid demanding WHO-GMP certification as a pre-qualification to participate in local tenders had been extremely favourable developments for them.
The Confederation of Indian Pharmaceutical Industries - SSI (CIPI) has taken up the cause of the SSIs and has decided to argue for the sector in the Supreme Court.
The Uttaranchal HC had observed that the "government of Uttaranchal has issued all necessary certificates which permit the manufacturer to manufacture and sell their medicine in open market from where the general public may purchase and use the same."
In this eventuality the state government cannot deprive the petitioners to participate in the tender process of supply of medicines to the government hospitals and dispensaries on rate contract, which will be ultimately distributed to the general public, it had ruled. The court observed that such conditions are unfair, unreasonable and arbitrary.
The High Courts of Andhra Pradesh, Uttar Pradesh and J&K had also given similar verdicts. The CIPI office bearers felt that the SSI sector has a strong chance of winning the case and once the SC verdict is in their favour, most the problems related with the participation in local tenders, can be solved.
Apart from the insistence for WHO GMP certification, the purchasing agencies also look at the turn over of the company before awarding the contract. SSIs feel that all these measures are discriminatory in nature.
The WHO GMP certification is a legal necessity if the company has to take part in international tenders or export their products. But for all local manufacturing and sales, the certificates issued by the state drug control authorities are valid. The SSIs complain that despite possessing a valid license to manufacture and sell drugs, they were not permitted to participate in the tender process by many of the state government agencies.