The Prime Minister’s announcement that prescription of medicines by their generic names will be mandatory has set the cat among the pigeons. It is not a well-thought-out move and diverts attention from the real crisis in public health and the lack of access to quality, affordable medicines for all.
At least 90% of the Indian domestic pharmaceutical market, of ₹1,00,000 crore and more, comprises drugs sold under brand names. There simply are not enough generic name equivalents of branded medicines sold. About half the market—₹50,000 crore and more—is for fixed-dose combinations (FDCs) of drugs, a further half of them irrational. Many FDC drugs contain even eight or nine medicines. To write, and remember, the constituents of FDC drugs in generic names is impractical, considering that there would be thousands of FDC brands.
Even if the doctor manages to write a prescription in generic names for single-ingredient drugs, pharmacists will sell the brand that maximises their commission and will in all likelihood not stock the less costlier but equivalent brand or generic medicine that is as good. This defeats the basic intention of making medicines affordable for consumers. Prescription by generic names merely shifts the focus of the pharmaceutical industry’s unethical drug promotion to the pharmacist; away from the prescriber, and resulting in business as usual. Medicines will continue to account for anything from 50% to 80% of treatment costs.
The Government of India has championed setting up Jan Aushadhis, which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings (PSUs) too. There are not enough Jan Aushadhis, possibly less than 3,000 against the more than eight lakh retail pharmacies in existence, with many rural areas still underserved.
To facilitate Jan Aushadhis, the Drugs Technical Advisory Board (DTAB) in May 2016 considered amending Rule 65 (11A) of the Drugs and Cosmetics Act, 1940 so that pharmacists can dispense generic name medicines and/or equivalent brands against prescriptions in brand names. The DTAB rejected the idea citing that the bioavailability of a generic drug may not be as good as that of the prescribed brand. (Bioavailability is a measurement of the extent of a therapeutically active medicine that reaches the systemic circulation and is therefore available at the site of action; whereas bioequivalence is the comparison of the bioavailability of two medicines, say the generic drug and the branded drug.) This means that the government’s top decision-making body on medicine-related matters does not have confidence in the products manufactured by the government’s own PSUs. The DTAB, however, could have recommended biowaivers on bioavailability/bioequivalence (BA/BE) for certain classes of drugs based on their permeability and solubility, a practice followed in countries where healthcare is well regulated. BA/BE studies are essential for certain critical dose drugs and drugs of narrow therapeutic range, which are few in number.
By implication, the DTAB has doubts that generic name medicines in general can have acceptable BA/BE at all. Probably, the DTAB is not confident that India’s regulatory agencies can strictly enforce quality requirements.
The Tamil Nadu and Rajasthan governments procure generic name medicines at extremely competitive prices year after year, and crores of drugs are in use in their public health systems, thanks to the quality assurance systems in place. The success of the drug procurement system in these two states should counter the defeatist narrative that insists that generic medicines can never be good. This is not to underestimate the challenges in ensuring quality generic medicines countrywide, but the critics from the medical profession are doing the poor patient enormous disservice by swallowing the disinformation from the pharmaceutical industry about the general lack of bioavailability of generics as compared to brands.
The Medical Council of India (MCI), in an amendment to the Code of Conduct for doctors in October 2016, has recommended that every physician “should prescribe drugs with generic names legibly … and he/she shall ensure that there is a rational prescription and use of drugs.” How the MCI is going to ensure rational prescription and use, without a framework to measure the same, is anybody’s guess.
Rational use and prescription depends on the doctor, the pharmacist, the regulator, and the consumer. Some minimum prerequisites for rational use are: prescription-only medicines (Schedules G, H, H1 and X) must not be available freely over the counter; doctors and their professional bodies along with regulators must ensure there is no misuse of antibiotics and critical drugs; and the removal of all irrational/harmful/useless medicines, both FDCs and unscientific single ingredients, must be ensured. Practical guidelines for rational use and prescription audit of medicines must be developed and implemented seriously by all doctors. Branding of off-patent drugs needs to be discouraged as is the practice in well-regulated countries. The Hathi Committee Report (1975) too had recommended debranding.
Price control of an enlarged list of essential and life-saving drugs is a must as was mandated by the Supreme Court in 2003. The current market-based price mechanism of the Drug Price Control Order (DPCO) 2013 is a travesty and has resulted in ceiling prices that allow 2,000% to 3,000% (and in some cases, 10,000%) margins. This needs to be replaced by the cost-plus method of ceiling price fixation of the DPCO 1995.
The number one priority must, thus, be the replication of the Tamil Nadu/Rajasthan model of free medicines in all states, and pharmaceutical PSUs must be re-energised and reinvented instead of the government disinvesting in them.
