IPA Opposes Generic Drug Substitution At Janaushadhi Kendras

New Delhi: A group of top Indian pharma companies has reached out to the central government opposing a proposal to allow government-run Janaushadhi Kendras to dispense substitutes of prescription medications, including anti-cancer, antibiotics, and habit-forming drugs, ThePrint has learnt.

At present, India has over 10,600 Janaushadhi Kendras or stores — a network of generic drug stores as part of the Centre’s Pradhan Mantri Bhartiya Janaushadhi Pariyojana aimed at making generic medicines affordable to the public.

The Central Drugs Standard Control Organisation (CDSCO) has been mulling a proposal to make changes in the Drugs and Cosmetics Act, 1940, and its associated regulations to allow the substitution of drugs specified under schedules H, H1, and X  with a view of promoting “quality generic medicines at affordable prices”.

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

Moreover, according to the rules, the details of the drugs included in schedule H1 and dispensed by pharmacists are to be maintained for three years and are open to inspections.

The drugs included in Schedule X, on the other hand, are strong habit-forming drugs. Every time these drugs are dispensed by a pharmacist, a copy of the prescription should be preserved by them for a minimum of two years.

Earlier this year, the CDSCO’s Drug Technical Advisory Board — which advises the regulator on technical matters about the Act — in its meeting recommended constituting an expert panel to assess the feasibility of allowing generic substitutions for these prescription drugs, provided they match the original in “substance, strength, and dosage form”.

However, the Indian Pharmaceutical Alliance (IPA) — a group of 26 top drugmakers in the country — in its letter to the Union health ministry last month, stressed that, if the recommendation was accepted for Janaushadhi stores, it would open floodgates of similar demands by trade channels, such as general pharmacy stores, “which will not be in the interest of patients”. ThePrint has seen a letter of the representation.

IPA partners include the biggest drugmakers 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 has also said that the absence of proper regulatory oversight could result in spurious drugs being dispensed to patients.

Citing 2023 data, the IPA noted that of the 7,500 drug samples tested over six months, 284 were found to be not of standard quality (NSQ), with 91 percent originating from category C firms — medium or small-scale generic drug manufacturers.

Once a drug’s patent expires, it becomes a generic medicine and can be made available under an official international nonproprietary name (INPN) or a brand. The INPN is the generic name of a medicine that is accepted globally.

However, in India — one of the largest global producers of generic drugs — these medicines are mostly sold in the form of branded generics, with IPA members being among the largest manufacturers.

According to IPA secretary general Sudarshan Jain, shifting the responsibility of prescribing generics from doctors to trade channels could severely undermine patient safety.

“Our channel partners are more likely to dispense drugs with a higher profit margin, regardless of the drug’s quality, which can result in spurious generic drugs being dispensed putting patient care and human life at risk,” he told ThePrint.

ThePrint reached Union health secretary Apurva Chandra over call but failed to get a response. This report will be updated if and when a response is received.

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

The National Medical Commission — India’s regulator for doctors and medical education — in its Registered Medical Practitioner (Professional Conduct) Regulations released last year introduced a provision to penalise doctors for failure to prescribe generic drugs.

However, the regulation was put on hold within days following strong protests by the Indian Medical Association (IMA) — the largest body of doctors in the country.

Many IMA members continue to highlight that any regulation to mandate generics for patients — either by doctors or pharmacists —will be detrimental to patient safety due to quality issues.

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

“At Janaushadhi Kendras, we trust the government to ensure good quality generics, but the data by state food and drug administration and the CDSCO are disappointing and suggest that less than 1 percent of the batches of these drugs are tested for quality,” he told ThePrint.

The experience of doctors in prescribing generics to patients based on the outcomes has been largely poor, he added.

Dr Ravi Wankhedkar, a senior IMA member and former president, also expressed concerns about substituting physician-prescribed drugs at pharmacies, including Janaushadhi stores, warning of adverse effects on patient health.

In fact, he said, “it may be a good idea to have One Nation, One Formulation, One Price — which will take care of the issues associated with both quality and pricing of medicines”.

Meanwhile, in its letter to the government, the IPA has pointed out that, following the quality drive conducted last year by the CDSCO to inspect adherence to good manufacturing practices at 137 facilities in various states, show cause notices were issued to 73 firms, while licences of 50 companies — mostly small and medium scale drug makers — were cancelled.

The IPA also mentioned that varying generic products could affect treatment outcomes for chronic conditions.

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

“Investments are made by branded businesses or companies through bioequivalence studies and clinical trials to bring these medicines to market to meet patient needs,” the alliance has said.

It also raised concerns about the current licensing norms, which allow new manufacturers to produce drugs without the Drugs Controller General of India’s approval if the drug has been on the market for over four years, leading to potential quality issues. The new manufacturers are only required to get approval from the state drug authorities.

“This leaves room for many substandard products in the market. Currently, only a few categories of products require bioavailability or bioequivalence studies, which are relevant for demonstrating uniformity in the safety and efficacy of products having the same composition,” the IPA told the government.

It has also been argued that the brands are associated with companies that are constantly investing in improving quality systems and delivering higher-quality medicines to the public. “Over time, this builds trust in the brands of associated companies for both doctors and the patients,” IPA highlighted.

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