Indian pharmaceuticals market is the third largest in the world in terms of volume. In terms of value it is ranked 13 in the world. It has the largest no. of FDA approved plants (around 500+) outside USA. The industry is expected to grow at 20% over the next 5 years. Currently, the industry is growing at 10-11%.
India made a turnaround after patents regime, by focussing on reverse engineering new process and to manufacture the same at low cost. India is still to become a player in terms of drug innovation.
The Government of India has unveiled 'Pharma Vision 2020' in 2013, to make India a global leader in drug manufacturing. It has reduced approval time for new facilities to boost investments. Further, the government has also put in place mechanisms such as the Drug
Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Ministry of AYUSH and Indian Council of Medicine Research (ICMR) from Belgaum in Karnataka have developed a drug to effectively counter dengue. They have already conducted pilot studies and double blind placebo controlled clinical trials which have proved the clinical safety and efficacy of the drug. The drug contains several herbal ingredients which have mentioned in Ayurvedic medicine. As of now, there are no effective drug to counter dengue and other treatments are done to provide relief from the symptoms.
India has imposed anti-dumping duty on import of ?Ofloxacin from China. The duty on import of ?Ofloxacin? from China will be in the range of $2.58 to $9.48 per kg for three years, said a notification issued by the Revenue Department in the Finance Ministry. The levy has been slapped following the recommendations of the Directorate General of Anti-Dumping and Allied Duties (DGAD). Ofloxacin is used to treat certain infections, including bronchitis, pneumonia and infections of the skin, bladder, urinary tract, reproductive organs, and prostate (a male reproductive gland).
The Indian Council of Medical Research (ICMR) and Pfizer are setting up a centre to address the growing threat of antimicrobial resistance in India. The ?Centre to Combat Antimicrobial Resistance? will come up in New Delhi . Pfizer will provide an initial grant of Rs. 67 million. The joint initiative will implement comprehensive interventions, ranging from antimicrobial resistance (AMR) stewardship programmes for nursing homes to scaling up of the ongoing AMR surveillance network and creating awareness around responsible use of antibiotics.
India's generic drug exports is growing at 22% over every year. According to Pharmaexil, generic exports accounts for around 20-22 per cent of the world?s production, covering more than 60,000 brands and 60 therapeutic classes. The APIs, generics and alternative systems of medicine ? climbed to $16.84 billion during 2016-17, with 34 per cent and 15 per cent supplied to the US and EU markets respectively. India has got extensive product portfolio, which provides the capability to manage and treat any ATC (Anatomical therapy classification) ? to the same quality as the innovators ? at highly affordable costs
Strides Shasun has received USFDA approval for promethazine hydrochloride tablets which is used to treat allergy symptoms, nausea and vomiting related to certain conditions. The product will be manufactured at the company?s Bengaluru facility and marketed by Strides Pharma Inc in the US market. The drug will be made available at strengths of 12.5mg, 25 mg and 50 mg. Currently, the market estimates for the drug in US market is USD 17 million.
India is planning to set up a Rs 500-crore pharma technology upgradation fund which will facilitate cheaper loans to entities looking to upgrade their manufacturing facilities. Under the Department of Pharmaceuticals, it is already working on a proposal to establish a venture capital fund with a same corpus to provide cheaper loans to small and marginal companies planning to set up new units. Proposals are under consideration to rejuvenate the domestic pharma sector and make medicines more affordable. The department is also contemplating to launch a scheme for giving financial assistance in form of soft loans or interest subsidies to select manufacturing facilities. The government is working on setting up parks for pharma products and medical device parks. The government is also planning
Karnataka government is planning to setup a pharma park in Mudipu in Mangalore in Dakshina Kannada district in Karnataka. The state government will provide 100 acres of land, while 170 acres of industrial land is available in the nearby Kanara Industrial Area. It is likely that the central government will be approached for the project. Karnataka Industrial Area Development Board is also set to improve infrastructure in the area.
Indian government is likely to commission a study soon to assess the impact of foreign direct investment in existing pharmaceutical companies. In recent years, there were spate of FDI in brownfield where global majors have acquired local companies. Now, there is a concern that generic drugs production in India will be affected. With affordable healthcare being a challenge in a poor country, allowing foreign MNC in a strategic sector may lead to monopoly. The market size of the India's pharma industry is estimated at over $20 billion.
Indian Pharma industry market is estimated at USD 15 billion and is growing at a rate of 12% per annum in September 2015. Top 20 companies account for 64 per cent of the market and the top 8 are growing faster than the market. The industry has seen a consolidation phases with several mergers and acquisition. Some factors that contribute to leading pharma market are a thorough know-how in the manufacture of generics, rapidly developing research and development facilities with talented technical staffing, internationally recognised systems of pharmacy education, and a broad patient population pool enabling intense clinical trials. India accounts for 30.3 per cent (2,911) of 9619 Drug Master Files (DMFs) filed with the US, which is the highest outside the US.