Supreme Court Favors Generic Drug Mandate for Doctors

In a Public Interest Litigation (PIL) hearing on the accessibility of medical services, the Supreme Court has remarked that doctors all over India should prescribe only generic drugs and not branded products. The suggestion was made to stop the unethical marketing practices of pharmaceutical companies.

The bench, which included Justices Vikram Nath, Sanjay Karol, and Sandeep Mehta, emphasized the need for prescriptions not to be brand-oriented.

 Justice Mehta remarked, “They cannot be prescribed by a company name. That direction was given in a PIL only. If this direction is made across the country, it will make a huge difference.” He also referred to a direction of the High Court of Rajasthan, which directs state doctors to prescribe only in generic terms.

PIL Attacks the Pharma-Doctor Nexus

The PIL seeks to impair the pharmaceutical companies' ability to coerce doctors into endorsing branded drugs, to the detriment of patients, claims the Federation of Medical & Sales Representatives Association of India. This is bound to cause over-prescription and inflate healthcare in a manner that adversely affects the Right to Health under Article 21 of the Constitution.

Senior Advocate Sanjay Parikh, representing the petitioners, stated that even though the law penalizes doctors who take medical promotions, pharmaceutical companies largely work under the voluntary code, thus promoting unethical marketing.

Advocate of Current Regulatory Codes

A clear legal parameter, the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) is a voluntary guideline on pharmaceutical marketing at the crux of the legal debate: it dissuades companies from giving gifts, travel, or any monetary benefit to doctors, but does not bar it legally.

However, the government countered by stating that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 already require doctors to prescribe generic medicines. Just recently, the National Medical Commission (NMC) has called for a halt in adhering to the Registered Medical Practitioner (Professional Conduct) Regulations, 2023, more stringent and meant to strengthen this rule.

In a discussion started by Dr. Munish Raizada, MD, FAAP at MedBound Hub regarding this matter, the young professionals had this to say:

Dr. Theresa Lily Thomas, BDS, said, "it is supposedly a step to stop the doctors being bribed by huge pharma companies.. let's hope it's in the right direction."

Dr. Sakshi Thakar (PT) said, "It's dicey decision…provided the govt is ready to take onus of any drug efficacy issues, transparency in maintaining the production and complete responsibility if any mishap happens due to faulty medicines. If they are advocating for it, they should guarantee or at least take responsibility."

Join the discussion at MedBound Hub: https://www.medboundhub.com/t/doctors-mandated-to-prescribe-only-generic-meds-what-you-think/1021

Government Weighs New Reforms

The Standing Committee on Health and Family Welfare has recommended not only making the UCPMP legally binding but also creating new legislation in this regard. The government admits to acting on these recommendations.

One glaring example that underscores the issue is the Dolo-650 case, wherein, from its manufacturers, the Central Board of Direct Taxes (CBDT) alleged that close to ₹1,000 crore worth free gifts were distributed to doctors for brand promotion.

What Next?

These observations of the Supreme Court could arguably trigger the creation of a new national policy and a shift of India toward cheaper, more ethical prescriptions. This particular case will then come up for further hearing in July.

(Input from various sources)

(Rehash/Muhammad Faisal Arshad/MSM)