The small and medium pharma enterprises (SMEs) in the country have asked the Union Health Ministry to introduce a Uniform Format for the entire country for issuing the certificate of pharmaceutical product (CoPP) instead of the proposed centralisation of CoPP. This may prove to be a major stumbling block to the pharma exporters as there is apprehension that the centralisation of CoPP will only help delay its issuance.

The SMEs argue that in a vast country like India, a uniform format would be ideal rather than the proposed centralization as in that case the exporters have to approach the DCGI office in Delhi or the few Zonal offices for CoPP which is issued for each product by the drug authorities. The exporters are concerned over the prospects of delays in issuance of CoPP by the CDSCO as exports are time bound and any delay will result in cancellations, which means loss of crores of rupees.

"Presently, FDA (Food and Drug Administration) in Maharashtra issues CoPP whereas SDCs (state drug controllers) issue it in some other states. There is a difference in format also. Instead of centralization the answer is creation of a common format which can be circulated to all states. Exporters have no objections to a Common Format," SME Pharma Industries Confederation (SPIC) secretary general Jagdeep Singh said.

As per the proposal, the CoPP will be issued by the CDSCO (DCGI office) from October 1 this year after the auditing by the CDSCO officials. There are apprehensions among the industry that given the infrastructure available with the CDSCO, it will not be possible for it to issue hundreds of CoPPs in a month all over the country. In Gujarat alone, around 800 CoPPs are issued every month. Industry sources said that the centralisation of CoPP will prove to be another bottleneck for the exporters, especially for the small and medium exporters, as they have to approach the DCGI office for each product in every two years for each product.

The exporters' apprehensions in this regard are not out of place as hundreds of applications regarding blood banks, rDNA-based vaccines, biologicals and large volume parenterals are learnt to be pending in the DCGI office for months, if not years. The power to issue licenses for these are lying with the DCGI office.

Singh also warned that such parochial policy changes in India will only help China to grab the export market of generic drugs just as it had grabbed the API (active pharmaceutical ingredient) market earlier due to such policies in India.