Drafting a road map to bolster the pharma sector
The outcomes from the recent Chintan Shivir will set goals for improvement in the regulatory system, making it contemporary and helping take the pharmaceutical and allied industry to the next level of operation for the good of public health
India is known as the pharmacy of the world, and there are several good reasons why it is called so. The country exports pharma products to over 200 countries, and its domestic pharmaceutical industry includes a strong network of 3,000 drug companies and 10,500 manufacturing units. India supplies over 50% of Africa’s requirement for generics, meets 40% of the generic demand in the United States (US) and provides 25% of all medicines in the United Kingdom (UK). The country also meets 60% of global vaccine demand and is a leading supplier of DPT, BCG and measles vaccines. The World Health Organization sources 70% of its required schedule of vaccines from India, and Indian firms supply over 80% of the antiretroviral drugs used globally. In addition, India also has a large pool of pharma scientists and engineers who can steer the industry to greater heights in the future.
Domestic pharmaceutical companies, which were largely recognised for their affordable manufacturing of generic medicines, are now being recognised for their high quality research and development ecosystem post Covid-19, a remarkable perception shift from being a volume manufacturer to value creator.
According to India Brand Equity Foundation, a trust established by the department of commerce, the domestic pharmaceutical market stood at $42 billion in 2021, is likely to reach $65 billion by 2024, and further expand to reach $120-130 billion by 2030 to become the leading provider of medicines to the world.
To figure out ways to maintain its pole position and improve the industry, the Union ministry of health and family Welfare, under Dr Mansukh L Mandaviya, held a two-day Chintan Shivir (camp for deliberation) on February 26-27 in Hyderabad on Drugs: Quality, Regulations and Enforcement. The meeting, attended by representatives from the Union ministry and state governments, had five areas for deliberations – building trust and confidence in the quality of drugs, cosmetics and medical devices in the domestic and export market; the effective enforcement of laws at the field level to ensure quality, safety and efficacy of the drugs till the last mile; the optimal use of Indian pharmacopoeia and adherence to its standards; capacity-building of state and national regulators for better and effective regulation of pharmaceuticals and medical devices; and the creation of a unified information technology platform for all regulatory activities.
Each segment had representations from the Union ministry and the states, with several state governments presenting successful case studies on these critical issues. The most important outcome of the Chintan Shivir was to sensitise and bring about an alignment among all stakeholders on the need for intervention and change in these areas.
Some of the critical recommendations included the need for the development of a unified regulatory system assisted by technology and a unified portal to be used by all central and state regulators; developing infrastructure and institution for continued support in execution and continuous improvement of the regulatory system; bringing about external support for micro, small and medium enterprises to ensure quality of their products and processes; the urgent requirement for time bound implementation of good manufacturing practice standards; the creation of positive and negative incentive systems for rule abiders and rule breakers; the need for periodic quality assessment by independent agencies, deep thinking in regulatory and quality domain, and the use of independent auditors; the removal of supply chain oversight for raw material and finished goods till the last mile; the need for structured capacity building exercises – continuous training to continuous evaluation; improvement in infrastructure and availability for testing, trained manpower, knowledge, efficiency, and field intelligence; creating a user-friendly system for customer complaints, grievance redressal, and communication strategy and data sharing.
The outcomes from the Chintan Shivir will set short-, medium- and long-term goals for improvement in the regulatory system, making it contemporary and helping take the pharmaceutical and allied industry to the next level of operation for the good of public health in India and the world.
Dr Rajeev Raghuvanshi is the drug controller general of India
The views expressed are personal