With a view to avoid duplication and unnecessary delay in the import of drugs already registered in the country as new drugs, the pharmaceutical industry associations have urged the Drug Controller General of India (DCGI) to take steps to scrap the Form 10 requirement to help the industry and make the norms up-to-date.
"We are now taking up with the authorities the stupidity of this clause of Form 10, which was introduced 25 years back and still being continued. The country had already introduced, over a decade back, the new drug registration procedures for the drugs being imported. It is time to withdraw this Form 10 provision in tune with the revised rules,'' said Confederation of Indian Pharmaceutical Industry (CIPI) chairman T S Jaishankar.
According to the existing provisions, every single company importing a drug should get licence in Form 10 from the DCGI for marketing it in the country. Industry points out that there was no need for such `duplication' of approval, when a drug already registered as new drug, is being imported.
``Any interested company should be allowed to import this drug which has been cleared as new drug after exhaustive and mandatory regulatory procedures. It means that drug is approved for the use of consumers and any company can be permitted to market it without further regulatory formalities. This Form 10 makes things more complicated unnecessarily and delays the procedures, affecting business of the industry,'' he said.
He said his association had already taken up the matter with the DCGI and will continue the efforts to get this provision withdrawn in the light of other existing rules.
A spokesman of SME Pharma Industries Confederation (SPIC) also supported the move by the CIPI to demand the scrapping of the provision which it felt was totally `unnecessary' and meant only to create more hassles for the drug companies in the country.