Prime Minister Narendra Modi’s recent statement of creating legal framework compelling doctors to write prescription of generic medicines has sparked off the debate on generic vs branded drugs in the healthcare sector.

While many common people and even experts in medical fraternity have welcomed the decision as it will provide an opportunity to the patients to buy generic medicines at cheaper prices, several others have expressed apprehensions over the success of objective of the move. Due to several reasons such a move will not result in patients receiving medicines at cheaper rate, claimed some while few others raised doubts over the quality of generic medicines.

However, no one can deny the need to make medicines available to the patients, particularly poor patients, at affordable rates. All the statistics released by the WHO clearly shows how the medical treatment is out of reach of large number of common people due to its high price and how expenses on medical treatments are pushing large number of families into the poverty each year.

Actually, the Medical Council of India has preceded the PM’s statement on the topic since its ethics code for doctors has made generic prescription mandatory since October 2016. But it has never been enforced. The PM is now thinking of making it mandatory by law.

The MCI’s regulatory code for doctors made generic prescription mandatory in October 2016 through a change in the code notified in the gazette. “The doctors’ code of conduct is only a code governed by the MCI that is not being followed. The council acts only if complaints are filed and the only penalty is suspension or cancellation of licence, which rarely happens, and it can be challenged in a court.

The new amended notification issued by Medical Council of India to all the dean/principals of all the medical colleges, director of all the hospitals, president (all the state medical councils), health secretary of all the states, director of medical education and director of health services saying that now every physician should prescribe drugs with generic names legibly and he/she shall ensure that there is a rational prescription and use of drugs. It also says that all the registered medical practitioners under the IMC act are directed to comply with the provisions of the regulations without fail.

Supporting the proposed move, Dr Praver Sharma, Medical Officer, Government of Rajasthan, said, “It indeed is a really good move by the government. If implemented properly, can be a game changer in long run as far as pharma industry is concerned.”

What are Generic Drugs?

A low-cost version of formulation that is equivalent to a branded product in quality, dosage, strength, route of administration and efficacy describes generic drugs.

It is a very common trend in India that even after expiry of patent protection; generic drugs are available under brands and are called ‘Branded Generics’. Companies spend good amount of money on branding and marketing of such products. Amending the guidelines can be a really crucial step towards ending this culture.

While showing his concern on the same SV Veeramani, President, Indian Drug Manufacturers Association said, “If doctors are made to prescribe only generics, the chemist might push medicines of companies that give him the highest margin, and there will be no accountability on quality.”

Echoing the same feelings, Pharma Sarabjit Kaur Nangra, Vice-President, Angel Booking said, “If the doctor only prescribes the generic name, it will be left to the chemist to decide which particular brand to push. So, the marketing focus of pharma companies will now have to shift from the doctor to the chemist.” She also pointed out that this kind of step might be practical in government hospitals but not across India.

However, there is one more viewpoint that doctors can give more choices. “Doctors can always prescribe multiple tablets instead of one. As far as quality is good, it did not make a difference as generally we always prescribe only generic drugs,” said Dr. Sunil Bhardwaj, Senior Doctor, department of Medicine, AIIMS.

Although government wants to ensure that doctors prescribe only by generic or formulation name of a medicine, there are people from the industry who are not in favour of this decision.

Dr S S Agarwal, former president, Indian Medical Association, said, “While the idea of only prescribing generics is good, it is not practical in India. The doctor’s job will now be only to diagnose the ailment. Using standard procedures of treatment for an ailment, the chemist will start selling drugs.”

Agarwal also highlighted other concerns related to the issue such as procuring generics is a problem in India, as domestic manufacturing is not robust. He cites the example Jan Aushadhi Stores where generics are sold at lower prices. “At any given time, only 200 of the 600 drugs that the government planned to sell at the Pradhan Mantri Jan Aushadhi Store are available. There has never been a day when all 600 drugs are there.”

Talking about the challenges, In India, off-patent drugs account for over 95% of the market. Marketing formula is very much brand based which is due to the largely Indian phenomenon of giving too much importance to drugs that have gone off patent but are sold under brand names rather than the chemical name of the drug by companies other than the original patent holder. This could be the main challenge for the India market.

Kalyani Sharma

(With inputs from Nitin Konde)