The Union government should go all out to mandate Prescription Audit to ensure that doctors prescribe affordable generic drugs rationally, said Dr B R Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka drugs controller.

Responding to the recent announcement by Prime Minister Narendra Modi to make a regulation to mandate that doctors prescribe low cost generic drugs to patients, Dr. Jagashetty appreciated the same and added that it was much awaited for India despite the need to address certain issues.

The current reality is the difficulty for doctors to remember and write prescriptions of medicines in generic names especially FDCs (Fixed Dose Combinations) containing 3 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 Pharmabiz.

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% 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.

“Another fact is that with Prime Minister being insistent to reduce cost of drug expenses for patients, whether existing pharmacy trade outlets are competent enough to dispense proper generic medicines professionally but not as businessman,” said Dr. Jagashetty who has comprehended the impending issues of generic supply chain management and prescriptions formats of medical practitioners.