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India streamlining the pharma sector? UPSC NOTE

 Why has the drug regulator tweaked norms for exports?

  • India's drug regulator has tweaked the norms for drug exports for a couple of reasons:

  • There have been allegations of substandard Indian drugs causing health problems in other countries.

  • Particularly cough syrups.

  • These tweaks aim to improve the quality of exported drugs and ensure they meet global standards.

  • The new regulations centralize authority over export drug manufacturing licenses with the CDSCO (Central Drugs Standard Control Organisation). 

  • This aims to streamline the process and potentially tighten quality control measures.

Where does India stand as a drugs manufacturer?

  • India is a key player in the international generic medicine market and any change in policy has a direct impact on manufacturers and importers, say industry insiders. 

  • The centralising of the licensing authority is significant, they point out, because according to a study conducted by the Department of Pharmaceuticals, India needs to get ready to take advantage of drug sales worth $251 billion going off-patent this coming decade.

Does the change follow allegations of sub-standard medicines being exported?

  • India is dealing with several challenges, including tackling intellectual property rights, lack of research and development etc. 

  • The study points out that understanding the political, economic, sociocultural, technological, environmental, and legal factors is vital for assessing the opportunities and challenges in the pharmaceutical market in India

  • The industry must adapt to changes in these external factors, navigate regulatory requirements, leverage technology advancements, and align their strategies with the evolving needs of the pharmaceutical

industry to succeed in the global market,” it noted. 

  • Speaking about the change, Raheel Shah, business development director, BDR Pharmaceuticals, says the move is welcome as the centralisation of NOCs will formalise the Indian pharma industry

  • This will result in the efficiency of the overall process along with bolstering pharma exports to key international markets.

  • It will help to bring uniformity in protocols, achieve the target of reaching $450 billion by 2047.

Will a centralising authority help, with several important drugs set to go off the patent list?

  • A centralizing authority could have both positive and negative impacts on access to important drugs going off patent in India:

Potential Benefits:

  • A central body could set pricing and production quotas to ensure essential drugs remain affordable and available throughout the country.

  • This could prevent regional price variations and shortages.

  • A central authority could streamline the approval process for generic manufacturers, encouraging more companies to enter the market and increase competition. 

  • This could drive down prices further.

  • A central body could have more clout when negotiating bulk purchases of raw materials or finished drugs, potentially reducing overall costs.


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