The Synergistic Revolution – India as a Generic Hub

“Generic Drugs are an important component in the Pharmaceutical ecosystem”

Affordable medicines are favourably accessible and come down to the promise of providing treatments within the budget of patients. Every rupee saved at the pharmacy store can be spent on life essentials and other basic requirements.  The need of the hour is to pave a reliable way in order to bring down the cost of medicines which can help the patients and at the same time boost the economic development of a country like India.

Among the developing nations of the world, India has already carved out a unique position for itself in many business grounds of the pharmaceutical industry and is presently being recognized as the ‘pharmacy of the world’ for the generic drug products. The Indian generics market is growing day by day with Indian pharmaceutical companies seeking more Abbreviated New Drug Application approvals (ANDAs) in the US. Indian Pharma market is growing at a very fast pace making Indian pharmaceutical industry rank third all over the world in terms of volume. Generic medicines are formulated when patent and other exclusivity rights expire. The birth of generics in the US took place through the enactment of the Drug Price Competition and Patent Restoration Act of 1984, public law 98-417 popularly known as “The Hatch- Waxman Act” which created a chance for the development and marketing of generics for 180 days. Under ANDAs a pharmaceutical manufacturer can develop and market low price generic version of previously approved innovator drugs, thus providing the same product to the patient which is economically feasible, safe and efficient. To ensure the therapeutic efficacy of generic products, it must be pharmaceutically interchangeable and bioequivalent to the originator product. The contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high i.e. about to 35%. To sustain competition from developed world Indian generic manufacturer should plan the market strategy and regulatory requirement needed, very quickly because for generics production a large number of application will be filed and competition from domestic market will also be there. It is seen that there is an upward swing in the generic market. It has reached 100 billion dollars in the past and is estimated to be three times higher than the overall growth of drugs. The current trend exhibits that blockbuster drugs are scheduled to lose their patent protection, opening the doors to cheaper generic drugs in the near future. To make the situation more favourable the Indian government has also introduced a scheme of providing generic drugs to a patient in hospitals with various Jan-aushadhi Kendra. Thus future prospects of generics in India is very high as they are the next big thing in health care scenario. Fortunately, India has the best subject skills to galvanize foreign investors. High R&D cost and investment in research is also a major stumbling block in this direction. In situations where demand for medicines exceeds supply, and cost-effective drug in demand with minimum expenditure, generic drug are the best choice fulfilling this demand.

Generic Drugs will help more people live healthier and longer by- driving down the cost of existing drugs & increasing competition means the payers also have a choice in the market place. Resources invested from the savings created by generic copies can provide a platform for the innovation of newer drugs for the most dreaded diseases in a country like India. An important aspect also lies within the uncompromised quality of generic drugs and that they are at par with the brand drugs. In order to ensure a continuous flow of generic drugs to the public, there should also exist a stage for the generic competitors. Generic drugs are, therefore, the sleek answer to this thick and burdensome rising prescription drug costs. Promoting timely access to quality standard generic drugs, understanding the dynamics of a brand and generic markets, providing a platform for generic drug development and advocating the use of these generic drugs are also the crucial links to affordable drugs. An important cornerstone of disease improvement is patient compliance, generics could be a key reason for increased patient compliance. In the therapeutic areas, the maintenance of chronic illnesses and diseases through generic drugs provide tremendous savings and valuable relief for people nationwide. Hence, a possible solution to this booming explosion of prescription costs could be the evolution of a generic drug.

-Janice Jacson, 3rd PharmD