Doctor Prescriptions Must Be Generic: Health Minister tells Parliament

New Delhi: Doctors should write the generic names of drugs in legible handwriting, preferably in capital letters, in the prescriptions, the Union Minister of State for Health Smt Anupriya Patel recently stated in the Rajya Sabha.

As per Smt Patel, the doctors' responsibility in this regard has been specified in Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, to ensure that there is a rational prescription and use of drugs.

Apart from this, directions in this regard have been issued to the doctors from time to time. States have also been advised to conduct regular prescription audits in public health facilities and ensure that the prescriptions include the generic names of drugs, informed the Minister.

She further added that the Directorate General of Health Services has directed all Central Government hospitals to ensure the prescription of generic medicines only. Similar instructions have also been issued to all CGHS Doctors and Wellness Centres.

The Minister provided the details in this regard while responding to the questions raised by Parliament member Shri Sanjay Yadav, who sought to know if the Government was aware of the extra financial burden imposed on a common citizen due to the huge cost of medicines, which is a lot extra when compared to the actual manufacturing cost of the same medicine.

Also Read: Doctors' Non-compliance with prescription guidelines continues to burden patients

Further, he asked if the Government could make it an Act for private doctors and hospitals to prescribe generic drugs to bring relief to crores of impoverished citizens every day.

In response, the Minister informed that as per the information received from the Ministry of Chemicals and Fertilizers, National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP), no such survey/research has been conducted by DoP.

"National Pharmaceuticals Pricing Policy, 2012 (NPPP, 2012) and the provisions of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) mandates the regulation of prices of formulations on the basis of market based pricing as against the cost-based pricing under DPCO, 1995," Minister Patel informed.

Regarding the query regarding issuing guidelines for generic prescriptions, she further mentioned, "Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 prescribes that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drug. Registered Medical Practitioners have been directed from time to time to comply with the aforesaid provisions. States have also been advised to ensure prescription of generic drugs and conduct regular prescription audits in public health facilities."

"The Directorate General of Health Services has directed all Central Government hospitals to prescribe generic medicines only. Similar instructions also have been issued to ‘prescribe drugs with generic name legibly’ to all CGHS Doctors and Wellness Centres," added the Minister.

"Under free drug initiative of National Health Mission (NHM), financial support is provided for provision of essential generic drugs free of cost in public health facilities," she further mentioned.

Medical Dialogues has been reporting on the efforts on the part of the regulatory bodies to make it a norm for doctors to write the generic names of medicines on the prescriptions.

Back in 2023, the National Medical Commission (NMC) on August 3, 2023 had released the National Medical Commission Registered Medical Practitioners Regulations 2023, through which, NMC encouraged doctors to prescribe generic medicines.

As per Section 8 of the NMC RMP Regulations 2023, "Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2)(Generic Drugs and Prescription guidelines)."

Similarly, Section 12(b) states, "RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2)"

Further, in the guidance to RMPs, the doctors were asked to prescribe drugs with "generic" names only. More importantly, the code of conduct had laid stress on generic prescription by doctors, adding that violation of the rules may result in punishment leading to suspension of the doctor's license for up to 30 days.

However, these regulations were opposed by the medical fraternity and IMA had earlier demanded deferring the implementation of the NMC regulations that make it mandatory for doctors to prescribe generic drugs, stating the biggest impediment to such medicines is the uncertainty about their quality. Stating that less than 0.1 per cent of the drugs manufactured in India are tested for quality, the association mentioned in a statement, “This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are not negotiable.”