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Context

• Doctors at central government-run hospitals and CGHS wellness centres have been warned by the Centre to follow generic medicine prescribing guidelines or face disciplinary action.

Introduction

• Hailed as the “pharmacy of the world”, the booming pharmaceutical industry of India is a leading source of cutting-edge innovation especially when it comes to providing life-saving medicines at affordable prices to people.
• Presently, it’s the largest international provider of generic drugs, which are the cheaper- but similar medicines as brand name medicine.

Generic Drugs

• Generic drugs can be defined as affordable versions of branded drugs which are brought into the market once the original drug manufacturer’s patent expires.
• These medicines have the same potency, quality, and implications and work in an identical manner as the branded drug. The generic medicines are marketed either by a salt or brand name.

Need for Generic Medicines

• The growing prevalence of chronic diseases like diabetes, cardiovascular disease, hyperthyroidism, hypothyroidism, etc., and sedentary lifestyle propel generic drugs market growth.
• Furthermore, the expanding aged population is contributing to the market growth as the comorbidities are more in the old population, thereby needing proper medications with the easiest route for drug administration.
• In developing countries like India, government bodies and other regulatory bodies have pushed manufacturers to launch effective generic drugs supporting pharma market growth. The introduction of 3-D printing technology helps in manufacturing generic medicines with varying release dates and tastes and has pushed the share of generic drugs in pharma industry.
• The short expiration and gap between re-filing of the new drug encourage various companies to produce generic drugs owing to rise in competition which further reduces the prices of the generic drugs. Also, enhancing accessibility to healthcare services and growing healthcare awareness among the public propel the pharma industry growth.

The Challenge

• Illegitimate drugs have been a challenging issue for India over quite a period of time. In 2018, the Central Drug Standard Control Organization (CDSCO) identified nearly 4.5 per cent of all generic drugs circulated in the domestic market to be substandard. Meanwhile, the issue begins with the lack of quality testing facilities across the country.
• In the US, there is a stringent quality control procedure and periodic quality check facilities in place, but India has a different story to tell as widespread corruption makes it a sidewalk to obtain a drug license through bureaucratic or political connections. Additionally, drug control procedures in India suffer from the lack of fund, resources and manpower and hence makes matters worse.
• Another issue is with the counterfeit medicines sellers who operate at the retail level and procure the substandard medicines from dubious suppliers.
• Also, many fraud chemist shops sell the counterfeit drugs illegally using the name of a pharmaceutical company that remains completely unaware of the incident. While fighting this issue is beyond the scope of a pharma company, it is very important that it is stopped immediately since it ruins the reputation of that particular pharma company.

The way forward for India

• Several initiatives are undertaken by government bodies towards awareness of the availability of generics like Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) under which PMBJP Kendras across the country will make quality generic drugs and implants accessible at affordable prices.
• This scheme is currently running in each state of India with its high popularity among the people with average to low-income categories providing the public access to affordable branded medicines.
• Furthermore, the Covid-19 pandemic has boosted the exports of generic medicines to a great extent, the developed and developing world are concerned about the high costs of patented medicines and looking for cheaper alternatives. Many countries across the globe are keen to use more generic drugs, in the long run, to cut down the cost of healthcare.
• According to study, the Indian generic drugs market stood at USD 24.53 billion in 2022 and is expected to grow at a steady compound annual growth rate (CAGR) of 6.97% during the forecast period.
• India’s domestic pharmaceutical industry is estimated to reach USD 130 billion by 2030 and the pharma market has sustained its growth momentum after the Covid-19 pandemic, according to the Economic Survey 2022-23 released on 31 Januray, 2023.

Lion’s share of the Generic drugs market

• The low cost of generics is an alternative to branded drugs and hence generics dominate, making up for 70 to 80% of the retail market.
• As India’s population grows, especially the aging population has significantly increased the demand for generic medicines on account of their affordability and effectiveness, which is same as branded medicines.
• According to some study, the global generic drugs market was worth USD 390.57 billion in 2020 and is projected to reach approximately USD 574.63 billion by 2030, attaining a compound annual growth rate (CAGR) of 5.59 per cent between 2021 and 2030.

Conclusion

• Generic medicines are low in cost but as effective and safe as branded medicines. In India, it is being widely used, the PMBJP aims to spread more awareness among people.
• Also, the pharmaceutical industry has shown tremendous progress and adapted to a changing environment which will help in achieving more success in generic drugs export from India.

PRACTICE QUESTION Q. Hailed as the “pharmacy of the world”, the booming pharmaceutical industry of India is a leading source of cutting-edge innovation especially when it comes to providing life-saving medicines at affordable prices to people. What role is India playing in the Generic Medicine Sector?