The Existing Drug Laws and their Enforcement Status; Paradox of Health Care and its Pitfalls

Anantha Naik Nagappa, Kunal Saxsena, Diasy P. A.

Pharmaceutical Industry - The Fore Runner
The Indian Pharmaceutical Industry has been endorsed as a champion and leader for its contribution of ensuring essential drugs at affordable prices and generating millions of jobs. At the same time there is a proliferation of branded medicines and small scale pharmaceutical industries following Indian Patents Act 1970, which liberalized the law of product patent in to process patent. There are 70000 branded medicines and 20000 Small Scale Pharmaceutical Industries registered in the country, following WTO regulations. Once again India introduced product patent and liberalized 100% foreign direct investment, opening the floodgates for harnessing the growth of pharmaceutical industries.
It is well known that population of India exceeds 1.1 billion and out of every seven people of the world, one will be an Indian. India spends around 6.1% of its Gross Domestic Product (GDP) on health expenditure. The life expectancy is around 64.35 years with an infant mortality rate at 56.29 1 deaths per 1000 live births. Although significant progress has been made in reducing poverty rates and improving infant mortality and life expectancy, the rate of growth in population seems to be a major blockade and acting negatively, depriving large sections of the population of health care. The other reasons for this paradox can be related to changes in social sector associated with growth in population and transition in epidemiology of disease.
Turnover of Indian Pharmaceutical Industry has grown at the rate roughly about 10% on the base value of 10 crores in 1948, to Rs.75000 crores. The industry comprises of 25% bulk industry and 75% formulations. Net export, which is about 65% of production, crosses Rs.33000 crores. There are more than 150 manufacturers with approval by US FDA, UK MCA, Australia and South Africa, where, many are in possession of WHO-GMP certificates.
India is ranked 4th largest, in terms of production volume after US, Japan and Europe, and 13th in terms of value. As far as the consumption of medicine is concerned, India ranks 2nd. India accounts approximately for 8% of world drug production. Indian Pharmaceutical Industry employs over 4.2 million personnel, both in manufacturing and ancillary sectors.


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