Report by Prashasti Kulkarni and Paridhi Agarwal
At the beginning of this month, the National Medical Commission, or the NMC, issued a few laws related to pharmaceuticals, among which was a directive that ordered doctors to prescribe generic drugs over branded ones.
Before we go further into this directive, let’s learn the difference between generic and branded drugs.
What exactly do “generic” and “branded” drugs mean?
When a company that makes medicines discovers a new drug, they gain a “patent” which allows them to stop other companies from producing and selling the same drug. This patent does not last forever, and during the period before its expiry, the medicine company produces and sells the drug under a “generic name” so that it can make a profit. After the patent expires, other companies can produce and sell similar drugs, under their own brand name, while keeping the generic name tied with the drug.
For example, when you go to the doctor with a fever, he/she might prescribe medicines such as “Dolo” or “Meftal.” But the generic name for these medicines is actually Paracetamol (in India). Paracetamol drugs all have the same active ingredients, are taken in similar ways, and have similar side effects. However, their brand name counterparts like Crocin and Dolo are sold by different companies and cost more to buy than just plain Paracetamol, because brand companies bear more investment costs than the generic ones, so they need more money comparatively and thus increase the drug’s price by 20-80%.
Physically, the difference between these medicines lies in their inactive ingredients, the ones that don’t affect their medicinal values, such as dyes for color, fillers, preservatives, all of which determine the size, shape and color of the drug. These factors vary in different brand medicines because there are Trade Laws in place which forbid them from making an exact copy of the generic drug. So, Dolo and Meftal and Crocin all have the same medicinal ingredients, side effects, etc. but they look different so they are not the exact copy of the original Paracetamol.
This is why patients are told to follow the doctor’s specific prescriptions because the inactive ingredients of these drugs can sometimes be harmful to certain patients depending on their medical history.
About the Generic Drugs Law
As mentioned before, the NMC issued a directive that banned doctors from prescribing on-brand drugs and urged them to prescribe generic ones instead.
This is because generic drugs are cheaper than on-brand ones, so the NMC feels that the implementation of this law could make healthcare affordable and accessible to everyone throughout the country.
Let us read about the advantages and disadvantages of this directive in further detail.
Advantages of this directive
The possible advantage of this rule if implemented would be a reduction in “out of pocket expenses” (expenses that are not covered under the health insurance of a person) for the patients as generic drugs cost less than the branded ones. For example: Let’s compare the clothes from a branded showroom and a local market. It is obvious that the clothes in the showroom will be more expensive than ones in the local market, and of better quality as well.
Disadvantages of this directive
- Quality- In our country there are still certain issues with the quality control of generic drugs available in the market. That is the reason that the doctors do not trust these drugs completely. Poor quality drugs might be harmful to the patients, and they also do not ensure that the patient fully recovers from the sickness. If the patient does not recover, then it will be the fault of the doctor and not the seller of these medicines.
- Control on dispensing- In a real-world scenario, if a government generic drug center (Jan Aushadhi Kendra) is not located nearby or the specific drug is not available, the people will have to go to a pharmacy nearby. Now, if the doctor has not prescribed a specific brand for the medicine required, the chemist will dispense the brand of their choice, thus making the whole exercise worthless.
- Multiple drug combinations- There are some drugs available in the market which have two or three types of medicines in one capsule, that are usually branded. Doctors prescribe these capsules, so that the patient does not have to take two or three different medicines. The patients, especially children, also do not want to take three different medicines at one time. So, this results in irregularity in consumption of medicines. This mandate will thus affect patient’s adherence to medicine as well.
Response to this directive
Due to the disadvantages mentioned above, doctors have responded negatively to the implementation of this directive, as it would compromise the quality of the care they provide.
Following this, the Indian Medical Association (IMA) and the Federation of Resident Doctors Association said that the directive could cause harm to some patients, as it “places a crucial treatment decision in the hands of non-medical personnel,” referring to the fact that pharmacies can just give their own branded drugs, as long as it ties with the generic drug prescribed by the doctor. In doing so, they might not be aware of the patient’s medical history, causing the patient to be at risk.
Additionally, the IMA said, in a press release, that instead of banning the prescription of branded drugs, the NMC should order manufacturers to produce drugs under the generic name.
A meeting between IMA and NMC followed the press release, where the NMC made a decision to put the order on hold until further notice, as mentioned in the Government of India Gazette on 24th of August.
Other laws passed by the NMC in 2023
The directive talked about above is part of the Registered Medical Practitioner (Professional Conduct) Regulations, 2023, issued by the NMC. Apart from the above directive, it included the following laws:
- Doctors and other medical practitioners can not receive any gifts or favors of any sort from patients, as this can come off as a bribe. This does not include the salaries received from organizations.
- The practitioners can not be involved in any third-part educational activity like seminars or workshops that involve sponsorships from pharmaceutical companies.
- The practitioners can not provide approval, recommendation, or endorsement to other companies/softwares/products/platforms that are related to medicine.
These are just some of the directives that were mentioned as part of the regulations. The others can be viewed here.