The Federation of Indian Chambers of Commerce and Industry of India (FICCI) has identified low investments in innovative R&D, weak linkages between industry and academia, low medical expenditure and healthcare spend, production of spurious and low quality drugs and shortage of psychotropic medicines as the major issues troubling the Indian pharmaceutical industry.
According to a FICCI report on Competitiveness of the Indian Pharmaceutical Industry in the New Product Patent Regime, the regulatory framework should be designed to encourage domestic industry to invest in R&D. It also emphasised the need to liberalise the Drug Price Control Order (DPCO), which puts unrealistic ceilings on product prices and profitability and prevents pharma companies from generating investible surpluses. The report notes that the lowering of tariff protection and the new MRP-based excise duty regime threatens the existence of many small scale pharma units, especially in Andhra Pradesh and Maharashtra that were involved in contract manufacturing for the larger players.
FICCI has suggested an eight-point agenda for action to boost the competitiveness of the phrama industry and cash in on the strengths and opportunities enjoyed by the industry. These include extension of deduction of 150% of R&D expenses, augmentation of the allocation of Rs 150 crore by the government for R&D to Rs 2000 crore, liberalized price control regime, academic-industry relationship based on the US model, income tax exemption on clinical trials and contract research done outside the company and overseas, encouragement to setting up of US FDA-complaint plants by providing tax holidays for a specified period etc.
In order to tackle the problem of spurious drugs, FICCI wanted the procedure for procurement of licence to be made more stringent, including extensive disclosure of detailed personal, financial and business information and a thorough background check. "There is a strong need to strengthen and streamline the Central and State Drug Control Organisations. State drug controllers should take measures like setting up of separate intelligence-cum-legal machinery with police assistance. Faking should be made non-bailable and cognizable offence and the prosecution should be instituted by any police or Central Bureau of Investigation officer not less than the rank of a sub-inspector (instead of an inspector in the extant provision). Most of the cases relating to spurious drugs remain undecided for years. Hence there is a strong need for setting up separate courts for speedy trials of such offences," FICCI noted.
It also wanted India to exploit its know-how in herbal medicines. "Since these medicines do not come under the purview of the TRIPS regime and the research in new chemicals entities involves millions of dollars of investments, the Indian companies should engage in R&D in herbal medicines. The companies should try to exploit the Indian traditional knowledge in ayurveda and herbal cures and file as many patents for herbal medicine as they can. For this the government should set up R&D laboratories undertaking research exclusively in the area of herbal medicines and support the companies in their research and patent filing," FICCI suggested.