Pannun assassination plot and India-US relations

In the US scheme of things, India...

The bliss of the Virgin Mary

Unconditional love is the driving force of...

Navigating India’s pharmaceutical evolution: A perspective on generics and challenges

BusinessNavigating India’s pharmaceutical evolution: A perspective on generics and challenges

India’s pharmaceutical sector has undergone a remarkable transformation, evolving from its modest origins to become a prominent global player in drug manufacturing. With a rapidly expanding population and an increasing focus on healthcare, the recent policy changes by the Indian Government regarding generic drugs have had far-reaching implications for both the pharmaceutical industry and the broader healthcare landscape.

The pharmaceutical sector has emerged as a significant force, driving innovation, cost-effective production, and the widespread availability of essential medications. This transformation has been characterized by strategic partnerships, technological advancements, and a commitment to enhancing healthcare accessibility within and beyond India. Presently, India is the leading global producer of vaccines and has established itself as the primary manufacturer and exporter of generic drugs. According to a recent report by Asian Lite, India now accounts for at least 13 per cent of the global pharmaceutical market.

At the core of this transformation lies the recent regulation introduced by the National Medical Commission (NMC) under the Indian Government, which mandates the prescription of generic drugs by all doctors. This paradigm shift prioritizes the affordability of medicines while also fostering innovation and research within the pharmaceutical industry. Although this policy represents a significant departure from the past, it is part of a journey that traces back to India’s independence in 1947. However, the implementation of this policy has soon got temporarily suspended following a meeting convened by the Union Ministry of Health.
Historically, India’s pharmaceutical sector was dominated by foreign companies, primarily American and European firms, which accounted for nearly 90 per cent of the market. However, the 1960s marked the beginning of a shift as the Indian government initiated efforts to promote domestic companies, leading to significant success in the 1970s. A crucial turning point came with the enactment of the Patent Act of 1970, a landmark decision that prohibited the patenting of medical products in the country. This paved the way for substantial advancements, enabling Indian companies to engage in reverse engineering, a practice that accelerated the mass production of drugs. Through meticulous analysis of existing drugs, Indian companies were able to replicate them, resulting in a doubling of firms operating in the sector. For example, Ibuprofen’s introduction in 1967 was swiftly followed by the introduction of its Indian generic counterpart in 1973. Similarly, Ciprofloxacin’s global debut was closely followed by the introduction of its Indian version within just three years. This drive enabled Indian companies to meet a staggering 95 per cent of the domestic drug market’s demands by 2006.

Nevertheless, this journey was not without obstacles. Low profit margins hinder research and development. In 1995, India signed the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to foster innovation. This agreement prompted amendments to the Patents Act and the establishment of research institutions like the National Task Force. Recent endeavours include the 2021 introduction of a Production Linked Incentive (PLI) scheme worth Rs. 15,000 crores, designed to boost domestic production and innovation. Importantly, the Indian Medical Association (IMA) and Indian Pharmaceutical Alliance (IPA) have expressed reservations about the new generic drug regulation released on August 2, citing quality testing concerns and advocating for a “one drug, one quality, one price” policy while the country’s apex regulator of drugs, the Central Drugs Standard Control Organisation (CDSCO), raised apprehension over the language in the notification.
As we navigate the intricate landscape of India’s evolving pharmaceutical sector, the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) emerges as a critical initiative that aligns with the policy’s objectives. The PMBJP, launched by the Government of India, aims to provide high-quality generic medicines at significantly reduced prices through a network of Jan Aushadhi Kendras (JAKs), specialized retail outlets offering generic medications. This initiative ensures access to essential medicines across the nation, bridging the gap between affordability and quality. Beyond retail, the PMBJP serves as an educational platform, raising awareness about the benefits of generic medicines and encouraging healthcare practitioners to prescribe these cost-effective alternatives. This aligns with the policy’s goal of fostering innovation within the pharmaceutical industry while ensuring affordable medical solutions. Notably, Prime Minister Narendra Modi’s pledge, made in his Independence Day speech, to increase Jan Aushadhi Kendras from 10,000 to 25,000 underscores the program’s significance.

However, incidents like what happened in the West African nation of the Gambia last year mustn’t be repeated. According to Gambia’s health administrators, many children began to sick with acute kidney injuries by consuming syrup locally. Four cough syrup variants – Kofexmalin Baby Cough Syrup, Promethazine Oral Solution, Magrip N Cough Syrup, and Makeoff Baby Cough Syrup, whose manufacturer was stated as Maiden Pharmaceuticals Limited, Haryana, India were found unsafe and toxic. With a high fatality rate, this attracted global attention.

The UN Health Agency laboratory analysis found ‘unacceptable amounts’ of diethylene glycol and ethylene glycol in the samples of each of those four products which are believed to be informally distributed to different markets. The All India Organisation of Chemists and Distributors (AIOCD) stated that none of the four syrups was available for sale in India. They are toxic adulterants used as solvents in liquid medication and can be fatal by consumption. Drug manufacturers often use substandard and cheap substitutes that contain diethylene glycol and ethylene glycol which may end in contamination. A similar incident happened in the Udhamour district of Jammu with the consumption of contaminated cough syrup called Coldbest-PC, manufactured in Himachal Pradesh. According to government sources, it was the fourth reported case of mass glycol poisoning in India after incidents in Chennai, Mumbai and New Delhi in 1973, 1986 and 1998 respectively.

A comprehensive analysis of the advantages and disadvantages of generic drugs sheds light on a landscape marked by cost savings, equivalence in quality and efficacy, increased access, and a resurgence of competition. However, challenges persist, including perception biases and bioequivalence variability. Solutions such as quality assurance, streamlined regulations, public awareness campaigns, and research incentives are proposed to address these challenges.
In assessing the broader societal implications of the policy, its potential to reshape healthcare accessibility and affordability comes to the forefront. Patient empowerment, rural healthcare advancement, gender equality, global collaborations, ethical considerations, and societal values intertwine in a complex tapestry. The policy not only redefines the dynamics of healthcare but also prompts ethical reflections on equity, social justice, and the interplay between profit motives and public welfare. But it is also important to make sure that the sale of generic drugs at a high profit rate does not affect the firms that manufacture quality generics by disincentivising them.

Hence, India’s journey in the pharmaceutical realm is one of transformation and progress. The policy on generic drugs acts as a catalyst, bridging the gap between public health and industry dynamics. Balancing affordability and quality while ensuring stringent oversight remains paramount. As the policy encourages generics, its successful implementation hinges on maintaining universal and high-quality healthcare. In essence, this transformative journey must continue, driven by innovation, equity, consensus, and the vision of a healthier, brighter future of quality and affordability. All stakeholders need to come together for this commitment.

Amal Chandra is a young author, student-rights activist, commentator, and accomplished graduate in Political Science from Pondicherry University.

Check out our other content

Check out other tags:

Most Popular Articles