The Drugs Controller General of India (DCGI) has instructed all State Drug Control Departments to avoid issuing WHO-GMP certificates to manufacturers of pharmaceutical products intended for domestic sales or supplies. The DCGI has also asked state DCs to advise all purchasing organization and departments in their states to refrain from insisting WHO-GMP certificates from Indian manufacturers.
The instruction has proved to be a major relief for small-scale drug makers who were finding it difficult to appear for local tenders due to the insistence of WHO-GMP certification as a pre-condition.
In a letter to all state drug authorities, DCGI has said that WHO certification scheme on the quality of pharmaceutical products, Certificate of Pharmaceutical Products (COPP) is only meant to be issued by the exporting country for the pharmaceutical products moving in international commerce.
"It is very clear that the COPP which describes the level of GMP compliance as per WHO norms is required only for the procurement agencies of international commerce and not for domestic market. The procurement agencies in India therefore may ask for GMP certificate relates to the compliance of revised Schedule M of Drugs and Cosmetics Rules and not for COPP (WHO GMP Certificate)," the DCGI has stated.
The DCGI clarification has been a long pending demand on the part of small and medium scale drug manufacturers of the country. The SSI drug manufacturers associations had also moved the court in several instances thereby challenging the insistence of government / public sector procurement agencies for WHO GMP as a pre-requisite. DCGI noted that several High Courts had also issued directions on the same line and accordingly refrained purchasing organizations / departments from insisting WHO GMP certificate.
Pharmabiz had recently reported the plans of the Confederation of Indian Pharmaceutical Associations (CIPI), a grouping of state level SSI pharmaceutical manufacturers associations, to represent the Central Government in this regard. The main demand of the association was to have a uniform guideline or the rule on WHO-GMP certification for the SSIs in all the states. The directive of DCGI has been precisely tuned to their long pending demand.