Indian Pharma industry going through a paradigm shift: Singh

Mumbai, Sep 10 (UNI) Stating that the Indian pharma industry was poised for a rapid growth to emerge as a credible force in the global pharma industry, Dr Surinder Singh, Drugs Controller General, Government of India, today said the government is trying to take several measures so that the industry realizes its dreams.

Dr Singh was speaking at the 6th Pharma Summit 2008: ''India Pharma Inc - An Emerging Global Pharma Hub'', organized here by the Confederation of Indian Industry (CII).

He outlined various initiatives taken by the government like revisions in the Patents Act, stringent measures to prevent making of spurious drugs and creation of pharma R &D fund with a corpus of US $ 33.3 million.

Dr Singh elaborated on the priority areas of DCGI office as establishment of single window for all clearances, fix timelines for each application being (2-6 weeks); meetings with industry representatives on fixed days; new drug application status on web; recruiting subject experts and reviewers both internal and external; building staff and infrastructure; training; responsibility and accounting; permit parallel drug testing; approvals and ushering a time conscious.

Dr Singh also stressed on the importance of having different regulations for medical devices and drugs, and mentioned that measures for this distinction will be taken shortly.

''The immediate steps contemplated are building infrastructure, manpower and training, time frame for approvals, to have overseas inspections by the early next year,'' Dr Singh explained.

He went on to elaborate new initiatives taken in the important phase of clinical trials. ''Analysis of molecules by LCMS, Radio labeling, monitoring of clinical trials, mandatory registration of clinical trials, which is currently voluntary, insurance coverage and fingerprinting of volunteers are also some of the steps, which will ensure reliability and credibility of this important phase,'' Dr Singh stressed.

''E-governance will bring reliability, accountability and timeliness and will be a major influence in bringing reforms in the Indian pharma industry,'' Dr Singh said, while highlighting the role of e-governance. He listed various e-governance initiatives contemplated by his department like LAN/WAN connectivity of CDSCO campus, online submission of all forms, digitalized interactive portal, digitalization of records and online approvals with digital sign.

UNI JM SR AG1741