The small-scale drug manufacturers in the country may soon initiate a concerted movement to pressurize the central government to direct the states not to insist on a WHO-GMP certification during the tender process for drug and surgical item supply to the government run hospital segment of various states.
Though the central government lacks constitutional powers to directly intervene and order the state governments not to insist on the certification, a clarification on the purpose of WHO-GMP certification and a directive to consider not insisting on the certification could help the cause of the industry, feel industry circles.
The Confederation of Indian Pharmaceutical Associations (CIPI), the apex organisation of state level SSI pharmaceutical manufacturers associations, is planning to represent the central government to issue the directive in the interest of the SSIs in various states, in the backdrop of the cases pending with various courts and the prevailing confusion with many state health departments.
CIPI would soon mobilize the opinion of various state level organizations in the issue and submit a memorandum to the Centre with all the data related to the issue, T S Jaishankar, chairman of CIPI told Pharmabiz.
So far, the state level pharmaceutical manufacturers associations were taking up the case with their respective Governments. For example, when the Tamil Nadu government insisted on WHO-GMP certification, TN PMA approached the authorities and successfully appealed to do away with the decision. In some other states, respective PMAs moved courts and obtained stay or favourable verdicts. However, the association felt it was necessary to have a uniform guideline or rule on WHO-GMP certification for the SSIs in all the states, said Jaishankar.
WHO-GMP certification is mandated only for companies who are into exports, and not for companies who want to manufacture and sell their products in the domestic market. More than 90 per cent of the SSIs in the country depend alone on local orders and caters only to the domestic market, noted sources.
It may be noted that at least five states like Uttaranchal, West Bengal, Madhya Pradesh, Andhra Pradesh, Karnataka and Jammu and Kashmir had insisted in the recent past to have WHO GMP certification for their Government drug procurement. Against this, the pharmaceutical manufacturers associations in many of these states had sought legal solutions. The verdicts of the High Courts of Uttaranchal, Andhra Pradesh, J&K and Uttar Pradesh had all supported the view of the SSI sector, and had agreed that WHO GMP should not be a pre-condition for participating in domestic tenders, as Pharmabiz had reported earlier. A few months ago, the Supreme Court had given a stay order on the Uttaranchal High Court verdict which favored the SSIs. The issue is still pending before the Supreme Court.
Though the Union Health Ministry had plans to order all the drug procuring agencies under its control to stop insisting on WHO GMP certification as a pre-condition for drug companies to participate in government tenders, the government is yet to implement the same.