Though the government move for bringing ‘a legal framework’ to make doctors prescribe generic medicines throughout the country is highly laudable, the successful implementation of the same needs the cooperation of all the stakeholders as well as ironing out the hitches at the ground level
"Doctors write prescriptions in such a way that poor people do not understand the handwriting and he has to buy that medicine from private stores at high prices," the Prime Minister said while inaugurating a multi-speciality hospital in Surat recently. "We will bring in a legal framework by which if a doctor writes a prescription, he has to write in it that it will be enough for patients to buy generic medicines and he need not buy any other medicines", he had pointed out.
To make this programme a success, the medical practitioners across the country have to cooperate and need to be competent. It will mean that they should remember the names of the active pharmaceutical ingredients containing in each of the medicines they prescribe. Most of the doctors may know chemical names of some of the widely used old medicines such as paracetamol, aspirin, ibuprofen, etc. But, a large number of them are not familiar with lengthy names of several others including hundreds of newly introduced other APIs. It will be all the more difficult in the case of Fixed Dose Combinations (FDCs) when a physician will have to remember the names of a number of ingredients.
In a situation like this, to ensure generic prescription by doctors is going to be a big task. Monitoring prescription practice in big private and government hospitals may be possible but to have check in thousands of primary health centres and private clinics run by doctors located in vast rural areas and semi urban centres is going to be very difficult. Now, next task is to make pharmaceutical companies and the retail trade to fall in line. Both these segments are against the move as they think the government plan will affect their business seriously. Pharmaceutical companies are solely depending on brand promotion of their products for their profitability. And the retail chemists are interested in storing and selling expensive branded generics and patented products as that only ensures higher trade margins to them. Considering these factors, co-operation of all the three groups are essential to make the PM’s goal a success.
However such a move by the central government is badly needed in a country where prevalence of both infectious and lifestyle diseases are increasingly impoverishing majority of the population. This is because the overall government spending on public health is far below in India compared to several developed and developing countries. The medicine cost as a component of treatment procedure for a patient is quite high in India because of the current prescription practice of medical practitioners. The practice among doctors is to prescribe branded generics and some times even patented drugs to patients. While patented drugs are highly unaffordable to the common man, several branded generics of multinational companies and large Indian companies are also expensive. Although National Pharmaceutical Pricing Authority is expected to regulate the prices of essential medicines, contradictions like different MRPs for the same branded generic with the same strength of different companies exist. And the doctors usually prescribe most expensive branded generics of the MNCs or big Indian companies. Probably this trend prevails because the retail chemists stock costly branded generics as only that ensures higher trade margins than the low priced branded generics.
Responding to the PM's announcement, Dr B R Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka drugs controller said the Union government should go all out to mandate Prescription Audit to ensure that doctors prescribe affordable generic drugs rationally, said
However according to him the current reality is the difficulty for doctors to remember and write prescriptions of medicines in generic names especially FDCs containing three or more drugs. This is where a prescription audit legislation could help. It would make it compulsory for a doctor to refer or remember generic drug names. It would also stall the threat of antibiotic resistance. The audit may be carried out randomly by a team of medical experts identified by the government along with personnel from the drugs control department, Dr. Jagashetty told
In 2012, the then Drugs Control General of India had issued a direction to all state licensing authorities to permit manufacture of medicines in generic names only. But on the contrary we saw manufacturers assigning and labelling the brand names of the drugs manufactured by them. Now this led the entire DCGI order to be defunct and unclear, he added.
With Prime Minister’s recent push for generics, the government should also put in place efforts to curtail the doctors writing unnecessary tests and drugs including antibiotics and nutraceuticals indiscriminately in a single prescription. More often we see such prescriptions to pinch the pocket of the patient, he said.
“Though Medical Council of India has amended its rules making mandatory for writing prescriptions in generic names only and also in capital letter format, it is gathered that hardly any of these medical professionals are following this direction. Therefore the challenge and the responsibility of the government would be to ensure stringent surveillance on the prescriptions,” stated Dr. Jagashetty.
The recently amended Drugs and Cosmetics Rules vide GSR 327(E) dated April 3, 2017 directs all pharma and biotech companies to submit the result of bioequivalence (BE) study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification. Now this can also be extended to all drugs including those for which permission is sought first time after lapse of 4 year period of new drug, he said.
The cost of medicines may be around 18-20 per cent of the total health expenses and thereby the government will now need to find a method to curtail other related expenses like diagnostics and other tests which more often are unwarranted, he stated.
Even as the pharmaceutical industry sector remains discontented over the Union government’s plan to frame norms for mandatory generic prescriptions, the Medical Council of India (MCI) has for the third time in three years urged doctors, hospitals and medical colleges to comply with its earlier orders with regard to prescribing generic medicines as far as possible.
MCI, the medical regulatory body, feels that despite repeated directions to physicians, institutions and government bodies, the medical fraternity is failing to comply its orders.
In its circular dated April 21, 2017 to the principals of medical colleges, director of hospitals, presidents of all state medical councils, directors of state health services, state medical educations and state health secretaries, the MCI has directed to ensure compliance of generic prescriptions by practising doctors and wanted them to inform the Council about the actions taken on the matter so far.