Alliance of India’s top 26 drug manufacturers reject substitution of generic drugs in Janaushadhi Kendras.

The Central Drugs Standard Control Organization (CDSCO) is proposing amendments to the Drugs and Cosmetics Act, 1940, and related regulations. allowing the substitution of drugs specified under programs H, H1, and X with the aim of promoting “standard drugs of high quality at low prices”.

Schedule H of the Act includes generic drugs while Schedule H1 includes 3rd and 4th generation antibiotics, such as cefixime and moxifloxacin, anti-tuberculosis drugs, and certain psychotropic drugs.

In addition, according to the rules, information on drugs included in the H1 schedule and provided by pharmacists must be kept for three years and open to inspection.

Medicines included in Schedule X, on the other hand, are powerful drugs of abuse. Whenever these drugs are prescribed by a pharmacist, a copy of the prescription should be kept by them for at least two years.

At the beginning of this year, the CDSCO’s Drug Technical Advisory Board – which advises the administrator on technical issues regarding the Law – in its meeting recommended the creation of an expert group to examine the possibility of allowing these prescription drugs, provided they comply with the first ” matter, power, and structure of values”.

However, the Indian Pharmaceutical Alliance (IPA) – a group of 26 top drug manufacturers in the country – in its letter to the Union Health Ministry last month, stressed that, if the proposal is accepted for the stores of Janaushadhi, will open the floodgates of similar needs. through commercial channels, such as conventional pharmacy stores, “which will not be in the best interests of patients”. ThePrint has seen the letter of representation.

IPA partners include major drug manufacturers based in India, including Sun Pharma, Dr Reddy’s Laboratories, Torrent Pharma, Piramal, Aurobindo, Emcure, Intas, Glenmark, Lupin, Cipla, and Cadila, among others.

The IPA also said that the lack of proper regulation could lead to fake medicines being given to patients.

Referring to the 2023 data, the IPA noted that of the 7,500 drug samples tested over a six-month period, 284 were found to be of non-standard quality (NSQ), and 91 percent came from group factories of C – generic or small drug manufacturers.

Once a drug’s patent expires, it becomes a generic drug, and may be available under an official international non-proprietary name (INPN) or trademark. INPN is the generic name of the drug that is accepted worldwide.

However, in India – which is one of the world’s largest producers of generic drugs – these drugs are often sold in the form of well-known generics, IPA members are among the manufacturers the elders.

According to IPA secretary-general, Sudarshan Jain, shifting the responsibility for prescribing chemicals from doctors to commercial channels could seriously harm patient safety.

“Our facility’s users have the opportunity to provide high-profit pharmaceuticals, regardless of drug quality, which can result in the supply of generic drugs that compromise patient care and health.” people in danger,” he told ThePrint.

ThePrint reached Union Health Secretary Apurva Chandra over phone but failed to get a response. This report will be updated when a response is received.

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The ongoing debate about generics

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002, currently in force, encourage doctors to prescribe generic drugs “as far as possible”.

National Medical Commission – India’s regulator of doctors and medical education – In its Registered Doctor (Professional Conduct) Regulations released last year introduced a provision to penalize doctors for failing to prescribe standard medicines.

However, administrative law it was caught a few days after strong protests by the Indian Medical Association (IMA) – the largest medical body in the country.

Many members of the IMA continue to emphasize that any regulations on prescribing generics for patients – whether by doctors or pharmacists – will be detrimental to patient safety due to quality issues. .

According to IMA president Dr RV Asokan, the use of conventional medicines by patients is justified in cases where the quality of these medicines can be ensured. However, the ground reality in India is different.

“Ho Janaushadhi Centerswe hope that the government will ensure that generics are of good quality, but the data of the national food and drug administration and CDSCO are disappointing and suggest that less than 1 percent of the groups of these medicines are tested for quality,” he told ThePrint.

The experience of doctors in giving generics to patients based on the results is very limited, he added.

Dr Ravi Wankhedkar, senior member of the IMA and former president, also expressed concern about the substitution of prescription drugs in pharmacies, including. Janaushadhi shopping, warning of negative effects on the patient’s health.

In fact, he said, “it might be a good idea to have one Nation, One Structure, One Price – which will take care of issues related to quality and price of medicine”.

Meanwhile, in its letter to the government, the IPA indicated that, following quality car made last year by CDSCO to check compliance with good manufacturing practices 137 centers in different countriesshow-cause notices were issued to 73 firms, while the licenses of 50 companies – mainly small and medium-sized drug manufacturers – were revoked.

The IPA also stated that different generic products can affect treatment outcomes for chronic conditions.

It added that a large proportion of products are not included in the Indian pharmacopeia, which provides an important basis for ensuring quality standards for manufacturers.

“Investments are made by well-known businesses or companies through bioequivalence studies and clinical trials to bring these medicines to the market to meet the needs of patients,” said the association.

It has also raised concerns about the current licensing practices, which allow new manufacturers to introduce drugs without the approval of the Drug Controller General of India if the drug has been on the market for more than four years, leading to potential quality problems. New manufacturers are only required to obtain approval from state drug authorities.

“This leaves room for many uncertain products on the market. Currently, only a few categories of products require bioavailability or bioequivalence studies, which are important for demonstrating the same safety and efficacy of products with the same structure,” the IPA told the government.

It has also been argued that brands are associated with companies that continually invest in improving quality systems and delivering high quality medicines to the public. “Over time, this builds trust in the products of related companies for doctors and patients,” IPA emphasizes.

(Edited by Richa Mishra)

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