With the DCGI going ahead with the proposal to centralize the issuance of Certificate of Pharmaceutical Products (CoPP), several drug manufacturers, especially the small companies in the country will have tough time in getting the manufacturing licences for their products which they otherwise would have received easily from one state drug authority or the other as the manufacturers so far had the freedom to approach another state if the drug is failed in one state.
Experts in the industry are of the view that since there will be uniformity in issuing the product licences by the CDSCO under which the DCGI office works, many drug units will not be able to get product licenses from the CDSCO that easily as there will be strict monitoring by the DCGI. The main reason for bringing the issuance of product licenses under the ambit of the CDSCO is to strictly comply the quality standards as per the WHO standards.
So far, the manufacturers had the freedom to go from one state drug authority to another for manufacturing licenses as there is no uniformity in product licensing in the country. As per the present system of licensing, even if a state drug authority, for instance Maharashtra, denies product license to a particular product, the manufacturer can approach any other state drug authority in the country for license. And almost all such cases, they manage to get licenses from 'weaker' states.
Experts say that there are several such instances in the past in this regard. It may be recalled that several pharmaceutical companies had received manufacturing licences for the irrational combination drugs from the states where infrastructure for testing the stability study to decide the rationality of the drug combinations were weak.
Several companies had exploited the weak states where there is only skeleton structure to carry out the stability study to verify the rationality or otherwise of the combination of two or more drugs. Several companies had received manufacturing licenses for irrational combination drugs from weak states like Bihar, UP, Pondicherry, Silvassa, Daman, etc. during the past before entering other developed states like Maharashtra, Andhra Pradesh, Karnataka, Gujarat, etc where infrastructure to carry out stability study is good.
The modus operandi of the drug companies is that they will first apply for manufacturing license for a drug in the weaker states. Once they receive the license from the state drug controller, they will market the drug all over the country for three-four years. Once it is established in the market, the drug companies will apply for manufacturing license in states like Maharashtra, Andhra Pradesh, Karnataka, Gujarat, etc.
As the drug has been in the market for some years and is doing well, the drug controllers in these states will also take a lenient view on giving the license.
Now that the issuance of COPP is being centralised, these types of gimmicks will become a thing of the past, experts believe.