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A recent Assocham study blamed 'red-tapism' for driving pharma companies in the country to shift research and development (R&D) work and clinical trials overseas, especially to South-East Asian countries of Cambodia, Korea, Philippines, Singapore, Thailand, Vietnam among others.
“Various South-East Asian countries are wooing India’s R&D industry by offering sops and transparent regulations as regulatory bottlenecks and a plethora of committees have slowed permissions and approvals for trials or marketing drugs to more than 12-15 months back home in India while such permissions are given by the USFDA, EU and Singapore within a month’s time,” according to a survey of Indian Pharma Industry conducted by The Associated Chambers of Commerce and Industry of India (Assocham).
Assocham interacted with about 250 top officials and representatives from India’s pharma industry based out of five states of Andhra Pradesh, Gujarat, Karnataka, Maharashtra and Tamil Nadu between March-June, 2013 to ascertain and seek solution to their concerns and problems. The Gazette Notification (No: GSR 53 (E) dated January 30, 2013) issued by the department of Health, Ministry of Health & Family Welfare has put a ‘full stop’ to the research and development (R&D) in India, triggering serious concerns amid entire pharma industry, said majority of the industry representatives interviewed by the chamber, Assocham claimed in a statement here.
“This notification is not in line with the established international standards and is likely to have a cascading effect on the future of clinical trials in India as the flaws in the gazette could negatively impact the future growth of R&D as well as development of low cost high quality medicines in the country,” Assocham said in a communication addressed to the Prime Minister, Manmohan Singh.
Assocham has also written to the Health Ministry also to immediately take action to prevent slowdown of clinical R&D in India while adding that global trials have almost come to a grinding halt in India over the past six months, consequently denying patients suffering from life threatening conditions access to brand new drugs.
South-east Asian countries like Cambodia, Korea, Philippines, Singapore, Thailand, Vietnam and others are emerging as preferable destinations for India's pharma companies to expand their business as they share similar patient population and disease profile and moreover, have a conducive environment for their operations like easy market approach without any regulatory uncertainty, highlights the survey.
“Flight of operations by India’s pharma majors will surely hit India’s image as a fast-growing, low-cost hub for medical research,” said D S Rawat, national secretary general of Assocham while releasing the findings of the chamber’s survey.
