New Delhi: The year 2023 did not start on a good note for the health and pharmaceutical sector in India.
Towards the end of 2022, the image of the country, which took pride in being termed the “pharmacy of the world” during the Covid pandemic, had taken a severe beating.
Several reports had surfaced last year of contaminated drugs, manufactured by makers in India, being supplied to other countries and leading to serious adverse effects and, in some cases, even death.
As a result, the government faced an uphill task of fixing the nation’s image and restoring the credibility of generics produced in the country.
Beginning 2023, the government announced a major crackdown on companies making spurious or substandard medicines.
The year also saw the launch of breakthrough drugs in India — from the first ‘living drug’ marking a significant milestone in the country’s cancer care landscape, to the government announcing crucial made-in-India drugs against rare diseases, bringing their prices down considerably and promising greater accessibility to the needy.
Meanwhile, the National Medical Commission — the regulator for medical education and doctors — came up with crucial but controversial decisions such as linking the number of MBBS seats with a state’s population, only to withdraw them following backlash from the medical fraternity and states.
Here is a recap of the 10 major developments that shaped India’s health sector in 2023.
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Course correction for ‘dubious drugmakers’
Following a spate of allegations of adulteration in India-made drugs, mainly cough syrups, Indian drug regulatory authorities started cracking down on companies making spurious or substandard medicines.
In the first phase, regulators listed 76 firms across 20 states for action, cancelled product permission for three entities and cancelled or suspended manufacturing in 18 firms in March this year.
According to details shared by the Union health ministry, the maximum number of “defaulting” drug manufacturing units identified for inspection are in Himachal Pradesh, the drug manufacturing hub of India.
Following the first phase, government officials said the exercise will continue in the months to come and violators will keep facing action, according to the norms.
Stricter norms for cough syrups headed outside
Following back-to-back incidents of some Indian drugmakers supplying adulterated drugs to other countries, the government decided that beginning 1 June, all batches of cough syrups meant for exports will have to be tested for quality in designated government laboratories.
The decision was implemented despite a pushback from the pharma industry which reasoned that the move could delay exports. Later, some private laboratories were also permitted to carry out the tests and the practice still continues.
Anti-smoking warning on OTT platforms
On 31 May — World No Tobacco Day — the health ministry notified new rules under the Cigarettes and Other Tobacco Products Act, 2003. The rules require over-the-top (OTT) platforms, or streaming services, to display health warnings during scenes featuring actors smoking.
This came after years of pushback by the OTT industry and campaigning by anti-tobacco activists.
Since the rule applies to films being shown in theatres and television channels, it only makes sense to extend it to the streaming platforms, the government reasoned. It also cited evidence that such warnings deter people, especially youngsters, from taking up smoking.
Ban on drug cocktails
In June this year, the health ministry published a gazette notification banning 14 fixed-dose combination (FDC) drugs citing lack of therapeutic justification and an expert committee’s recommendation for the prohibition.
The drugs in the latest notification were used for treating cough, common infections, fever and body ache, and included combinations such as Nimesulide + Paracetamol dispersible tablets, Amoxicillin + Bromhexine and Pholcodine + Promethazine.
The move impacted several big pharmaceutical companies, including some multinational companies, some of which challenged the decision in the Delhi High Court. The court asked the government to allow drugmakers to clear their existing stock, much to the dismay of pharmaceutical experts.
Announcement on NExT
The National Medical Commission announced in June that the first National Exit Test (NExT) — a common licentiate examination to replace university-level final MBBS examination, National Eligibility-cum-Entrance Test-PG (NEET-PG) and Foreign Medical Graduate Examination (FMGE) — will be conducted in May 2024.
However, following an outcry from students and later instructions from the government, the commission said the test — clearing which will be a must to get a registration as a doctor to practice medicine and which will also serve as a test for postgraduate selections for all specialties — will begin only from 2025.
The commission was also forced to withdraw the detailed notification on NExT after the health ministry wrote to it pointing out discrepancies in the proposed norms.
Focus on GMP compliance
As part of a slew of measures to ensure better quality of drugs being manufactured in India, the health ministry announced in August that all drugmakers with an annual turnover of over Rs 250 crore will have to mandatorily adopt good manufacturing practices (GMP) within six months, starting 1 August.
Companies with a turnover of less than Rs 250 crore will be given a year to complete the process, it said.
This was followed by amendments in the GMP norms, making them, in some cases, more stringent than even World Health Organization guidelines.
Subsequently, several workshops and meetings have been organised by drug regulators for drugmakers, particularly those running micro, small and medium-sized businesses, to sensitise them about adherence to the norms.
NMC flip-flop on conduct norms for doctors
In yet another example of flip-flop by the National Medical Commission (NMC), it was forced to put on hold in August the Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The regulations, among other changes, introduced a provision to penalise doctors for failure to prescribe generic drugs.
The notification led to an outcry among medical professionals, particularly the Indian Medical Association — the largest network of doctors in India — which said that India is not yet ready for widespread use of generic medicines, or non-branded generics, given the quality issues.
The health ministry had to intervene and it too, endorsed the view, and was reported to have admitted internally that the move may not be practical.
MBBS seats linked with population
A notification by the NMC restricting setting up of new medical colleges across states and linking the number of MBBS seats to population was deferred for a year following protests by some states, including Uttar Pradesh and Tamil Nadu.
The NMC had earlier said it will allow new medical colleges with only 50, 100 or 150 MBBS seats, provided that existing MBBS seats did not exceed the 100 seats per 10 lakh population formula.
The dictated ratio of 100 seats for every 10 lakh population, however, would have restricted all five southern states from opening new medical colleges, since they already had the required number of seats. Also, Uttar Pradesh has come up with new colleges that are looking at inauguration next year.
All this led to intervention by the health ministry once again and the commission was forced to defer the decision for a year.
Launch of breakthrough cancer therapy
The year saw the launch of the first “living drug” in India, marking a significant milestone in the country’s cancer care landscape.
The Central Drugs Standard Control Organisation, in October, approved the first CAR (Chimeric Antigen Receptor) T-cell therapy — a cutting-edge immunotherapy developed by ImmunoACT, a company incubated at the Indian Institute of Technology Bombay, for the treatment of leukemia and refractory or relapsed lymphoma (cancers of the lymph system).
The company has collaborated with nearly 20 hospitals across the country, including the top cancer hospital in India, Tata Memorial Centre in Mumbai, to launch the treatment and aims to make it available to patients for about Rs 30-40 lakh.
Those earlier willing to undergo this treatment had to travel to countries like the US where it cost Rs 3.3 crore.
Affordable drugs for rare diseases
The central government in November announced that the first four made-in-India drugs for rare diseases, also called orphan diseases, which will bring down costs of the medicines by up to hundred-fold, have been launched in the country this year.
All drugs used for treating rare diseases were so far being imported and were prohibitively expensive, often forcing people to crowdfund treatment.
As part of the project, the health ministry has identified 13 priority diseases for which generic drugs will be made in the country and may be available over the next few months. There are nearly 8-10 crore estimated rare disease patients in India, according to government estimates.
(Edited by Nida Fatima Siddiqui)
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