India and Generic Medicines

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

                                               

 The term ‘generic’ word in India denotes the medicines which are marketed under a generic name. Then there is another term called ‘Branded generics’, to connote medicines which are now off patent and sold under a brand name by companies, this represents almost all the drugs in the Indian Pharmaceutical market.

On October 2012, Government of India issued a direction that the drugs will be sold within a generic name instead of their brand names. It caused an uproar in the medicines manufacturing communities in India.

                                      In a recent study, India’s trade margin for several branded medicines varies from 200% to more than 2000%. Not only this, the practice of self-medication is widespread in the nation among several socio-economic groups is similar to the practice of over the counter drug dispensing. Indian patients end up paying exorbitant prices for over the counter drugs bought from local chemists as they are unaware of the profit margins on simple antibiotics, painkillers, cough syrups or antihistamines.

Overpricing of medicines

With the escalating prices of medicines in India because of the progressive dismantling of price regulation system, the Drug prices control order (DPCO) had to put a price limit on 348 medicines which decreased to just 74 by 1995. Now, it is a patient’s perception that if the price is low, then the medicine is of poor quality. However, there are several reasons for generic medicines to be cost-effective. The 1st i.e. patented brand need to repeat their animal and clinical study regularly to validate the drug’s effectiveness and safety to the authorities. Generic medicines are only released in the market once the patent for its brand-name expires. As there is no associated brand or promotion, the cost will ultimately be low. Secondly, some companies dealing in generics intend to provide affordable medicines to people and earn from the volumes as against branded medicines sellers who intend to earn short term profits.

Indian Pharma Industry

India’s Pharma industry has been in news in the West because of its exceptional growth due to exports but the domestic market and the status of the industry is unknown. With more 20,000 registered drug marketing companies in India under the Central Drugs Standard Control Organization, 550,814 and 150 are registered with the World Health Organization, US FDA and European Directorate of Quality Medicine have high-profit margins. They adhere to the norms set by the body to meet the standards. And different pharmacopoeia standards add to the complexity.

In the midst of several objectives and issues, Government of India took various initiatives to eliminate the differences (price as well as quality) visible within the same molecule be it is generic or brand.