The Central Government of India demands every doctor in India to prescribe only the generic name of the medicine and not to write the brand names. Many states in India, including Kerala have already adopted this guideline into their system. This article is an open letter to the honourable prime minister of India Sri Narendra Modi and the union health minister Sri J.P Nadda on the facts related to the issues of the new prescription rules, solutions to the current issues and the stand of IMA (Indian Medical Association) written by Dr A Marthanda Pillai, ex-national president of IMA.
Indian Medical Association has always supported prescription in generic name provided the government can ensure quality of the drugs manufactured or available in our market. The generic drug prescription is a complex issue.
1. The quality control mechanism in our country is very weak. When India has more than 67,000 drug formulations, the quality control mechanism in our country can ascertain the quality of only 15753 drugs annually (Combined testing capacity of all the Central Drugs Testing Laboratories)
2. The bioavailability of any drug depends on its concentration, presence of impurities and mode of release of the drug, the concentration of the drug in the blood and storage conditions
3. A 2014 study found that 10.9 percent of the products were of poor quality-that is, they either contained none or less than the required dosage of active pharmaceutical ingredients. Of this 10.9 percent, 7 percent contained less than the required dosage of active ingredients, while 3.9 percent were drugs without any of the necessary active ingredients. Drugs without or with less than the required pharmaceutical ingredients will be ineffective, and therefore potentially harmful since they won’t cure the condition they’re meant to address.
4. There is no mechanism in our country to ensure all the above factors related to quality of the drug.
5. Legal issues and drug prescriptions;
Time and again, major adverse events including death occur due to poor quality of drug or contaminated drugs. e.g one of the major reasons for number of deaths that has occurred in the sterilisation camp held in Chhattisgarh have been due to contaminated drug used as antibiotics.
The verdict of the Chhattisgarh High Court in this issue has gone in favour of the doctor. He has been exonerated and the death has been due to sub standard generic drugs used during the operative course.
“26. Accordingly, the present CrMP is allowed. The entire criminal prosecution against the petitioner arising out of the FIR dated 11.11.2014 registered as Crime No. 350 of 2014 at Police Station Chakarbhata, Bilaspur and the subsequent prosecution case in Sessions Trial No. 37 of 2015 stand quashed.”
When generic prescriptions are insisted, in our country anybody can buy any medicine from drug stores even without prescription (Off the counter sale of drugs). In fact the sale of drugs in a medical store is more off the counter than through prescription. How these can be regulated?
The cost of same molecule (drug) varies considerably in our market. The price control mechanism is not even enforced to cover the essential drugs.
If you look at the ground reality, even if a doctor writes prescription in generic name/trade name, either way in the government hospital, the pharmacy will give only those drugs available there. In a private hospital, the management decides on which drugs is to be purchased and issued. In both situations, the prescribing doctor is helpless
The sales persons in the medical store decide the brand name if the doctor is not writing brand name. Even if doctors prescribe in the generic name, while dispensing it will be the sales person in the medical store who has no knowledge about drugs who is going to decide which brand of drug is to be given. (Medical store, although registered under a pharmacist, it is the salesman who deals with the dispensing of medicine and not the pharmacist.) This situation will be more dangerous and detrimental to the patient where the right and responsibility of prescribing a particular brand of drug is entrusted with the salesperson in the medical store, and if a adverse reaction or death occurs due to spurious drug, the doctor will be legally responsible and not the salesperson.
By shifting the responsibility of choosing the brand to the salesperson in the drug store, the objective of reducing the cost of drug is not going to be achieved.
If the government is serious about making drugs cheap and affordable, government should insist on the pharmaceutical manufacturers to market drugs in generic name. Without curbing the issue at the manufacturing level, putting the onus of prescribing cheaper drugs on the doctors is not a wise decision
When the government allows manufacturing of combination drugs, even irrational combinations, it is not easy and practicable to write generic names. For example cough syrup-combination drugs for neuropathy. Government will have to ban combination drugs in that case.
AYUSH drugs are also being used by our population. No quality control mechanism of these drugs is in place. In fact AYUSH drugs are much more expensive than many of the modern medicine drugs. No effort on the part of the government to encourage ‘generic prescription’ for cost control is visible.
Even our day to day commodities carry ISI mark before they come into the market. But no batch of drugs available in the market carries the seal of quality. Only when life is lost, the drug is sent for quality assessment.
Making drugs cheaper and affordable
Although the government’s intention in insisting on generic name is to make drugs cheaper and affordable, just putting the onus on the doctors alone will not help the purpose. The root cause of the problem has to be analysed and solved by a multi-pronged approach.
Solutions to the problem
1. Government to strengthen the quality control mechanism in drug manufacturing and to ensure that each batch of drug available in the market is quality checked
2. Government to enforce that all manufacturers to use only generic name for labelling their products.
3. Government to see that the cost of the same drug is uniform across all manufacturers, which in itself will make drugs cheaper
IMA is prepared to use generic names once the government is able to fulfil all the above. Till then, IMA strongly object to generic prescription in the interest of public health and patient safety.
Thanks and regards,
Prof Dr A Marthanda Pillai,
Past National President,
Indian Medical Association