The small scale drug manufacturers are of the opinion that the Government should clearly come out with specific explanations on quality criteria while introducing quality as the bench mark along with L1 purchasing system, instead of the turnover criteria, for bulk procurement of medicines by public sector institutions or organizations.

They cite that at present many public sector institutions insist different criteria like WHO-GMP, revised Schedule M etc. on quality while inviting tenders, apart from the most common turnover criteria as the basic eligibility. Unless, clear-cut quality parameters and conditions are defined, various institutions would interpret the rules differently, they fear.

If WHO-GMP were introduced as the basic quality criteria, it would be more detrimental to the interests of the industry. At present WHO-GMP is issued for export purposes and only for specific products. The certificate is issued only after a joint inspection of the CDSCO and the state drug control department. Currently, severe shortage of staff with the CDSCO and with most of the State DC administrations causes inordinate delays in joint inspection.

Due to this, manufacturers are forced to wait for more than six months to get the WHO-GMP certification and the Certificate of Pharmaceutical Products (CPP) needed for export purpose in many of the states. In this scenario, if WHO-GMP were mandated as criteria for supply to PSUs, only existing exporters would be benefited. Further, it would be impossible to apply for the tenders, having deadlines of not more than one or two months.

Lack of clarity may also allow many institutions to mandate US FDA or UK MHRA plant certification as quality criteria, if they want to exclude small-scale players. Many PSU organizations currently follow this practice in many states.

Sources said Revised Schedule M certification should be the appropriate eligibility condition. However, this cannot be mandated at least until 2007-end as even 10 percent of the inspections have not been carried out. If the Government mandates the new norms immediately with this condition, most of the SSIs may not be able to participate in the forthcoming tenders.

As Pharmabiz reported, the Government is planning to introduce a set of quality testing parameters for participating in government supplies thereby making quality assurance an equally important component of the tender system. The ministry move may result in the introduction of another level of screening before the companies that are interested in government tenders. SSI units, unless they brace up their quality parameters, may find the new specification difficult. It should be noted that the need for quality check in government drug purchase was pointed out by the Prime Minister's Task Force headed by Dr Pronab Sen some months ago.