New Delhi: Following a massive protest by medical practitioners as well as different health associations across the country, the Union Health Ministry recently withdrew a notification asking the medical practitioner for mandatory prescription of generic drugs. The notification was issued by Ethics and Medical Registration Board (EMRB) of the National Medical Commission (NMC).
Amid a tussle over branded and generic medicines, experts, however, opined that there should be price regulations over branded medicines. While the prices of drugs included in the National List of Essential Medicines (NLEM) are strictly controlled, for drugs which do not form part of the NLEM, companies are permitted to take a 10 per cent price increase over the Maximum Retail Price (MRP) prevalent in the preceding 12 months.
The NMC notification had earlier stated that every registered medical practitioner (RMP) should prescribe drugs using generic names written legibly and prescribes drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. The Indian Medical Association (IMA) had demanded its withdrawal stating that it should not be enforced till there is assurance that the medicines meet quality standards.
"The biggest impediment to generic drugs is the uncertainty about their quality. The quality control in the nation being very weak, there is practically no guarantee of the quality of drugs and prescribing drugs without assured quality would be detrimental to patient health. Less than 0.1 per cent of the drugs manufactured in India are tested for quality. Patient care and safety are not negotiable," Dr Anilkumar J Nayak, Secretary General of IMA told ETV Bharat.
The IMA was spearheading the protest against NMC’s notification on the mandatory use of generic drugs. He argued that if doctors are not allowed to prescribe branded drugs, then why such drugs should be licensed at all, given that modern medicine drugs can be dispensed only on prescription of doctors of this system.
"Government, if serious about implementing generic drugs, should give licence only to generics and not to any branded drugs while ensuring quality of generic drugs," he pointed out.
Dr Nayak said that there should be a fool proof system of quality assurance before switching over to generic drugs. On the other hand, the government is of the view that prices of generic medicines are 50-90 per cent less than that of branded medicine prices in the open market.
While giving a reply over the steps taken for promotion of generic medicines in, Minister of State for Health Dr Bharati Pravin Pawar has recently informed in the Lok Sabha that 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP) has been implemented by Pharmaceuticals & Medical Devices Bureau of India (PMBI), a society under the aegis of the Department of Pharmaceuticals, wherein about 9,512 dedicated outlets known as 'Pradhan Mantri Bhartiya Janaushadhi Kendras' (PMBJKs) have been opened till June 30, 2023 to provide quality generic medicines at affordable prices.
"Prices of medicines sold through these outlets are 50-90 percent less than that of branded medicine prices in the open market,” she said.
The Centre has also launched a mobile application 'Janaushadhi Sugam' that provides information to the public about the location of kendras, help them search 'Janaushadhi' medicines and compare the maximum retail price of generic versus branded medicines, she said.
Dr Pawar said under the free-drug initiative of National Health Mission (NHM), support is provided for provision of essential generic drugs free of cost in public health facilities.
"Only quality generic medicines are sold through PMBJKs. In order to ensure quality of the products, PMBI procures medicines only from World Health Organization – Good Manufacturing Practices (WHO-GMP) certified suppliers. Apart from this, each batch of drug is tested at laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL). Only after passing the quality tests, the medicines are dispatched to PMBJP Kendras," Dr Pawar clarified.
Difference between Generic and Branded drugs:
A drug may have one or more main components that provide the medical treatment. Each of these components, also called active ingredients, has a unique name to easily identify it. This is the generic name, for example paracetamol or ibuprofen.
Drugs can also have a branded name given by the manufacturer or pharmaceutical company to make it recognisable and memorable. For example 'Advil' and 'Motrin' are branded names although both contain the same active ingredient – ibuprofen.
"The domestic pharmaceutical market is mainly a 'branded generics' market in which pharma companies sell off-patented drugs under their own brand names with varying prices among competitors. Branding and marketing activities remain important in pharma companies' sales strategy," said renowned health expert and former finance secretary of IMA Anil Goyal.
A senior health ministry official told ETV Bharat that people can go for medicines of their choice or as prescribed by the medical practitioners.
Experts believe that the latest guidelines from NMC was a part of the government's efforts to improve healthcare affordability by promoting the use of unbranded generic medicines that cost up to 80 per cent -90 per cent less than the branded versions in some cases. However, branded medicine continues to account for over 75 per cent share by volume and 90 per cent by value.
"Yes the market share of branded medicine is much higher than generic medicine. There should be a regulation over pricing of branded medicine following the fact that the price of some branded medicines is much higher," said Dr Suneela Garg, renowned health expert and former advisor in the Indian Council of Medical Research (ICMR).
As of now one is not sure of the quality of generic medicines. The patient comes to the private practitioner with the trust that they will get the best advice and treatment for which they pay. So the trust and confidence of private practitioners is important in medicines, Dr Garg added.
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