Although India has a somewhat well drafted Drugs & Cosmetics Act and other statutes to regulate the pharmaceutical sector, the implementation of these legislations has not been very satisfactory. This is mainly because of the fact that the enforcement of these Acts and rules are being done by the drug control administrations of state governments. As all the drug control departments in different states are not competent enough to interpret these complex rules, there has been no uniformity in execution of various provisions of these rules in the country. This situation has created a lot of confusion and disputes in this industry to the detriment of the public at large. Formation of a Central Drug Authority was contemplated by the government considering these realities and the fast pace of growth of Indian pharmaceutical industry over the years. The need to centralize the drug control administration in the country was felt on account of the urgency in bringing some uniformity in enforcement of various laws. Licensing of pharmaceutical products has been one area where there is a lot of confusion still prevails in the country. A new drug is approved for marketing in the country by CDSCO but issuing licenses for its manufacture is done by various state drug administrations. A mechanism to introduce Central drug licensing system is still under discussion in view of the opposition from the state drug control departments.
However, as a first step towards centralization of the drug control administration in the country, the CDSCO has now decided to start issuing Certificate of Pharmaceutical Products (CoPP) for medicinal products for uniformity and compliance to WHO guidelines. Currently, CoPP is issued by the state licensing authorities after a joint inspection by state drug authorities and the DCGI office. It is issued for an individual product for the purpose of exporting that particular product alone. The license is issued after a unit makes an application in a prescribed format along with purchase order from the buyer of that particular product. The power to issue these certificates was actually delegated to the SLAs by the CDSCO earlier in view of the shortage of manpower in CDSCO some time ago. But, it has been observed that the certificates issued by the SLAs of different states are often at variance to the guidelines of WHO Certification Scheme. Often their interpretations are not proper and even the prescribed formats are not adhered to. In fact, WHO had written to the office of DCGI objecting to the practice of giving the title of "WHO GMP Certificate" by the SLAs. As expected most SLAs have expressed strong resentment against the proposal to centralize the issue of CoPP. They should realize that majority of the state SLAs are not equipped enough to handle this job effectively. With CDSCO now being strengthened at all India level on a fast track basis, it should be able to take back the responsibility from SLAs and grant CoPP as per WHO norms and fulfill the international obligation.