Thursday, 20 July 2017

PM’s statement sparks debate on generic vs branded

27 April 2017 | News

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 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

Editor's note: Prime Minister Narendra Modi’s recent announcement of forming a legal framework to make doctors prescribe generic medicines, and not branded one, has not only sparked off generic vs branded debate but, it requires a series of steps to reach the benefits of the idea to the needy people. Doctors is merely one joint in a chain that promotes branded medicines, which are costlier than branded medicines. Though nobody denies the need for such a step to provide much necessary relief to the patients in a society where diseases are growing affecting more number of people and the cost of treatment too is ever growing. All studies from organisations like WHO clearly indicate how large number of people are being pushed out of treatment due to poverty or how more and more families are becoming poorer due to treatment expenses. In a country, where health insurance is still not widespread and the government spending is very low on health, people are left to their own destiny on afflicted by sickness. If the government could not increase its spending on health, what at the most it could do is reduce people’s spending on healthcare by using its authority to control the drug prices. That is what government plans to do now. But there are many hindrances in the way which needs to be removed. The first and foremost is doctors’ knowledge of generic names. In case of some very common medicines there won’t be any problem. But for many other medicines, doctors will have to learn once again the difficult and long generic names. May be a legal framework will have to be followed by training and workshops for doctors. Monitoring the implementation of the rule is also another problematic issue in view of the large number of individual medical practioners spread to smaller places, where the need for generic prescription is more.. Second hindrance is retail chemist. They receive hefty commissions from MNCs and big Indian companies for their branded drugs. Naturally they maintain stocks of branded generic drugs and are not much interested in generics. Alleged doctor chemist nexus is also side issue in this. MNCs and big Indian companies is the third integral part of this chain. They obiviously will not be in favour of such a decision as that will affect their sales and profits. They connect with doctors on one hand so that they remember the branded drug while writing prescription for a patient and with chemists on the other that they store those medicines. Legal framework in PM’s mind will have to monitor, control and curb all these practices only then it will be able to provide some relief to a sick common person and his/her family from the current problem of high expenses of medical treatment.

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)

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