India is the world’s third largest producer of medicines and pharmaceuticals, exporting to around 200 countries/territories. | Photo credit: Getty Images/iStockphoto
History so far: India’s drug regulatory body, the Central Drugs Standards Control Organization (CDSCO), has withdrawn the powers devolved to state licensing authorities to issue NOCs (no-objection certificates) for manufacturing unapproved, banned or novel drugs for export. This latest announcement on medicines for export comes at a time when India is under scrutiny over allegations of supplying substandard medicines causing health problems in several countries. CDSCO is currently the only authority that issues licenses for the manufacture of medicines for export.
What is India’s role in the pharmaceutical market?
India is the world’s third largest producer of medicines and pharmaceuticals, exporting to around 200 countries/territories. The Indian pharmaceutical industry meets 62% of the world’s vaccine demand and is a leading supplier of DPT (diphtheria, pertussis and tetanus), BCG (Bacillus Calmette-Guérin, mainly used against tuberculosis) and measles vaccines. The center noted in a statement tabled in parliament that at least 70% of WHO vaccines (according to the core vaccination schedule) come from India.
What will be the impact?
India is a key player in the international generic medicines market and any policy change has a direct impact on manufacturers and importers, say industry insiders. They point out that the centralization of licensing authorities is significant because, according to a study by the Department of Pharmaceuticals, India needs to prepare to tap $251 billion in drug sales going off-patent in the coming decade.
The study noted, “The pharmaceutical sector in India will undergo disruptive changes between 2022 and 2030 as several drugs are expected to go off-patent and enter the generic market. The patent expiration is very promising for the Indian generic drug market as it is expected to expand and grow further with the inclusion of these novel drugs. With continuous development, India has begun to focus on self-sufficiency on a gigantic scale. Therefore, it is necessary to identify these drugs in advance and develop and implement strategies that will support in their timely entry into the market by promoting the production of generic drugs.”
What are the challenges?
India faces a number of challenges including the issue of intellectual property rights, lack of research and development, etc. The study pointed out that understanding the political, economic, socio-cultural, technological, environmental and legal factors is crucial to assess the opportunities and challenges in the market sector pharmaceutical in India. “The industry must adapt to changes in external factors, meet regulatory requirements, take advantage of technological progress and adapt its strategies to the changing needs of the pharmaceutical industry in order to succeed in the global market,” it noted. Talking about the change, Raheel Shah, director, business development, BDR Pharmaceuticals, says the move is welcome as the centralization of NOCs will formalize the Indian pharmaceutical industry. “This will result in the efficiency of the entire process and strengthened exports of pharmaceutical products to key international markets. This will support standardize protocols and achieve the goal of reaching $450 billion by 2047,” he added.
What about production quality?
Article in British medical journal titled “Indian government cracks down on 18 pharmaceutical companies for destitute production quality”, noted that the Indian government has revoked the licenses of more than 10 pharmaceutical companies as part of its fight against destitute production quality. This action in March last year came after an inspection of 76 pharmaceutical companies in 20 states. “It is also understood that the government has issued notices to a further 26 companies for failing to follow good manufacturing processes. India’s pharmaceutical industry is estimated to have 10,500 companies, and drug exports have more than doubled in the last decade. “However, the industry has recently faced a number of scandals, including a World Health Organization investigation into four contaminated cough syrups that caused acute kidney injury and were linked to the deaths of 66 children in the Republic of The Gambia last year,” he added.
In what appears to be an attempt to maintain tight control, the latest CDSCO order states that pharma companies will have to obtain their NOC from CDSCO zonal offices online before applying for manufacturing licenses from the concerned drug regulatory authorities in their state/UT . Drugs Controller General of India Rajeev Singh Raghuvanshi said the decision has been taken to facilitate the application process. In 2018, CDSCO allowed state and UT licensing authorities to issue export licenses for certain specified medicines. Under the novel regulation, local regulators will have to provide CDSCOs with details of all permits issued between August 2018 and May 2024.
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The centralization of power did not happen overnight, says an industry expert. The Central Government’s Drugs Advisory Group had noted earlier this year that obtaining NOCs from local regulators for pharmaceutical products is a tedious process leading to delays. Says Harish K. Jain, president of the Federation of Pharmaceutical Traders: “We do not anticipate any major impact on costs or delays from this latest move. The export of goods is on the EU list. Furthermore, the central authority has always been the central government; the power to issue drug export licenses was delegated to states several years ago.”
