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India is the world’s largest maker of generic drugs. The Indian pharmaceutical sector fulfils over 50% of the global demand for various vaccines, 25% of all medicine in the UK and 40% of the US’s generic drug demand. when a physician prescribes a drug, she either uses the drug’s brand name or the generic name. The brand name is the name the drug’s original maker or patent-holder has given. A generic version of the same drug uses a different name called the generic name.
Whenever a drug is invented and fits the criteria for patentability, a patent is granted to the applicant for up to 20 years, giving the owner of the intellectual property a limited marker monopoly to recover their expenses. After the patent expires, the drug falls into the public domain and becomes available to use without license.
The WHO defines a generic drug as a pharmaceutical product usually intended to be interchangeable with the originator brand product, manufactured without a license from the originator manufacturer, and marketed after the expiry of the patent or other exclusivity rights.
In the post-expiry phase, other drug-makers may manufacture the same drug and sell it under an international nonproprietary name – typically at a lower cost. Because generics break this affordability barrier, Indian law allows doctors to prescribe generic drugs to patients and for pharmacies to sell them.
A generic drug contains the same active substances that the branded version does and gives the same clinical results – irrespective of whether they have different colours, shapes, tastes or prices.
There are media reports at periodic intervals about doctors prescribing branded drugs that are out of reach of those who don’t make enough to purchase them. Note here that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 mandate doctors to prescribe generic versions of drugs in legible writing (preferably in capital letters) and also ensure that the prescription and use of drugs is rational.
In May 2016, the Drugs Technical Advisory Board of India considered amending Rule 65 (11A) of the Drugs and Cosmetics Act 1940 such that pharmacies sell generic drugs to patients even if the prescriptions specify the branded versions. In a public statement on April 17, 2017, Prime Minister Narendra Modi acknowledged the need for a law that mandates doctors to prescribe generic drugs when possible. Five days later, the Medical Council of India released a circular addressed to the medical community, stating: “For any doctor found violating clause 1.5 of Ethics Regulation, suitable disciplinary action would be undertaken by the concerned SMC/MCI.” The government has also authorised State Medical Councils to punish errant doctors with anything between suspending their license to terminating it.
According to the World Bank, India has a lower-middle-income economy – most Indians India belong to the economic lower-middle class. Parallely, India’s pharmaceutical market is worth almost Rs 1 lakh crore, of which 90% is owned by branded products. Generic drugs are typically 30-80% cheaper than the original versions.
The advocates of generic drugs have claimed that they are as effective as their branded counterparts. However, detractors have said they often prolong illnesses or sometimes even end in therapeutic failure. To bridge this credibility gap, the Union health ministry amended the rules “to make bioequivalence studies compulsory for certain classes of generic drugs manufactured in India.”
Then came Katherine Eban’s influential book, Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma (2019). In the book, Eban revealed how Indian pharma companies produce cheaper but also ineffective drugs for sale in India but expensive and effective drugs for exports. Since then, there has been a greater awareness of the fact that generics drugs need to be tested for their purity, potency, stability and drug release, and that the government should regulate the acceptable values of these parameters in order to ensure only good-quality drugs enter the market.
Many Indian doctors disfavour generic drugs for two main reasons: more people have a better awareness of branded drugs in both urban and rural areas, even if they are more expensive; and because doctors often receive a ‘commission’ from drug-makers for prescribing particular branded drugs. Medical shop owners also receive kickbacks and have been known to push branded drugs for this reason.
Generic drugs neither hamper nor discourage innovation. In fact, they should be marketed more aggressively so that people can afford good-quality healthcare. The Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana in 2008, under which it would provide good-quality generic drugs at affordable prices. Thus far, it has opened 7,290 distribution centres around the country; there should be more.
The socio-economic impact of COVID-19 has been such that the common person’s capacity to spend has come down on average. At this time, but also in general, the people need to be vigilant and know their rights. They should always request their doctors for generic drugs where possible; if there are no alternatives, they should discuss their concerns and needs with their doctors. Doctors should also be more conscious of their obligations and do their part to improve access to healthcare.
Sajid Sheikh is an assistant professor and Gunjan Deshpande is a research assistant to the DPIIT IPR Chair – both at the Maharashtra National Law University, Mumbai.