Indian Generic Drugs Seeing Sky-high Demand from International Market

A generic drug is a low-cost version of an existing approved brand name drug; having similarities in terms of ingredients, dosage form, safety, strength, route of administration, quality, and reactions or performance characteristics. Such drugs are often 30% to 80% cheaper than their branded equivalents. More and more pharma tablet manufacturers in India are getting inclined to produce generic drugs in recent the years, considering its growing popularity. 

The Advent of Generic Drugs in India 

The Government of India, in the year 2008, through the Department of Pharmaceuticals, launched the revolutionary pharmaceutical initiative called “Jan Aushadhi”,  meaning ‘Medicine for People’. This venture aimed at providing low-cost unbranded medicines, having quality similar to that of branded drugs; to the lower-income mass in the country, via the retail outlets setup by the government. These outlets are termed as the Jan Aushadhi Stores, which are pharmacies selling only generic name medicines and also providing assistance to the pharmaceutical public sector undertakings as well. 

It was until March 15, 2018, that around 3200 Jan Aushadhi stores were operating across more than thirty states and union territories in India. Hence, this data shows that the number of running Jan Aushadhi stores, of around 3200 against more than 8 lakh retail pharmacies, was not a decent number; with many rural areas being totally ignored. 

Popular Act and Regulations Passed in India for Use of Generic Drugs

The Medical Council of India, in an amendment to the code of conduct for doctors in October 2016, had recommended that every physician should prescribe drugs with generic names legible and he or she shall ensure that there is a rational prescription which promotes the use of generic drugs. 

In the Drugs Technical Advisory Board of India in May 2016 considered amending Rule 65 (11A) of the Drugs and Cosmetics Act, 1940, so that pharmacists can dispense generic name medicines and/or equivalent brands against higher-priced branded drug names in prescriptions. 

Products or Items falling into the Indian Generic Drugs Sector

Indian pharmaceutical companies including the otc products manufacturer hold a promising part in the generic drug market. The main items included by the pharmaceutical exporters in India are as follows: 

  1. Generic Drugs
  2. Active Pharmaceutical Ingredients
  3. OTC medicines 
  4. Patented Drugs
  5. Biosimilars

Important Facts and Figures About Indian Pharma and Generic Drugs 

India enjoys an important position in the global pharmaceuticals sector. The country has a large pool of scientists and engineers, with the potential to maneuver the industry ahead to greater heights. 

  • India’s pharma exports grew by 11% in FY 2019. 
  • Globally, India ranks 3rd in terms of pharmaceutical production by volume and 14th by value. 
  • The domestic pharmaceutical industry of the country includes a network of 3,000 drug companies and aroud 10,500 manufacturing units. 
  • Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. 
  • The country is accounting for 20% of the worldwide supply by volume and supplying about 60% of the global vaccination demand. 
  • In August 2021, the Indian pharmaceutical market increased at 17.7% annually, up from 13.7% in July 2020. According to India Ratings & Research, the Indian pharmaceutical market revenue is expected to be over 12% year-on-year in FY22. 
  • According to a report prepared by FactSet, the total Indian Research investment in generic drugs increased by 3.8% of sales in 2010 to $12.55 billion. 
  • As per IBEF, India is currently the largest provider of generic drugs globally. 
  • The Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. 
  • Indian generic drugs account for 20% of global export in terms of volume, making the country the largest provider of generic medicines globally. 
  • In July 2021, Generic Health (an Australia-based subsidiary of Lupin Limited) signed an agreement with Southern Cross Pharma Pty Ltd. (SCP). 
  • In February 2021, Glenmark Pharmaceuticals Limited launched SUTIB, a generic version of Sunitinib oral capsules, for the treatment of kidney cancer in India.
  • The global market for generic drugs is estimated to grow from $411.6 billion in 2020 to $650.3 billion by 2025, at a compound annual growth rate (CAGR) of 9.6% for the period of 2020-2025. 

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Immediate Necessary Actions Needed for Indian Generic Drugs Manufacturers and Exporters

  • For the country to retain its position as the largest generic drug supplier, the Indian generic drug sector must invest heavily on innovative research and development projects. 
  • It must continue improving the regulatory compliance of manufacturing sites, as well as keep developing cost-effective and high-quality manufacturing processes. 
  • Reducing the industry’s dependence on the imports of pharma raw materials or the Active Pharma Ingredients (APIs), key intermediates and starting materials will be key to sustaining its global leadership position. 

It is great to see that the Government of India has already started taking steps on this line; as on January 2021, it announced to set up three bulk drug parks at a cost of Rs. 14,300 crore (US$ 1,957 million), in order to manufacture chemical compounds or APIs for medicines and reduce their imports from China.