Generic Drugs in India: Lack of Popularity and the Road Ahead
Generic drugs are those medications that are fabricated to function the same as brand-name drugs. They are ditto formulations in the context of amount of dosage and its strength, administration method, quality, safety and usage.
We can state that the generic drugs are similar to the brand-name drugs in terms of bioequivalence and effectiveness.
They are comparatively less popular and prescribed in India due to quality concerns, a lack of awareness, and malpractices during manufacturing processes.
This scenario raises concerns about the prospects of generic drugs in India. The road ahead in this situation seems to be challenging and bumpy for Indian pharmaceutical companies.
What are Generic drugs in India?
Generic medicines are bioequivalence of brand-name drugs, so their safety and efficacy remain the same as the originals. As the counterparts of patented medicines, they are more pocket friendly and readily accessible to the public.
They are available in every medical institution, whether it’s government or private. As the patent on the original drug expires, the marketing of generic medicines is allowed after seeking approval from regulators like the Food Safety and Standards Authority of India (FSSAI) and the Central Drugs Standard Control Organization (CDSCO).
Due to their efficacious results and affordability, generic medicines are promoted by healthcare providers and the government. The rise of generic medication can solve the problem of the scarcity of drugs on the market and promote a healthy life among the country’s citizens.
Importance of Generic Medicines
Generic medicines offer numerous advantages that enhance their importance in society. Some key benefits are mentioned below:
Market Analysis of Generic Drugs in India
Current Market Share Statistics
The generic drug market in India holds a significant portion of the pharmaceutical industry. As of 2023, generic drugs constitute approximately 70% of the total pharmaceutical market in India.
This dominance is driven by the affordability and accessibility of generic medications compared to branded drugs.
According to a report by the Indian Brand Equity Foundation (IBEF), the Indian pharmaceutical sector is expected to grow to USD 130 billion by 2030, with generic drugs playing a crucial role in this expansion .
Comparison with Branded Drugs Market Share
While generic drugs dominate the market, branded drugs also hold a substantial share. Branded drugs account for around 30% of the pharmaceutical market.
The higher cost of branded drugs often limits their widespread use compared to generics, especially in a price-sensitive market like India .
Growth Drivers for Generic Drugs in India
The expiration of patents for several high-revenue drugs has opened up opportunities for generic drug manufacturers. Between 2020 and 2025, patents for drugs worth over USD 20 billion are expected to expire, enabling generic manufacturers to produce and sell these drugs at a fraction of the cost of their branded counterparts .
The Indian government has implemented several policies to promote the use of generic drugs. The Jan Aushadhi Scheme, launched to provide affordable medicines to the masses, has significantly boosted the generic drug market.
Additionally, the Drug Price Control Order (DPCO) regulates the prices of essential medicines, ensuring that they remain affordable .
Indian Government Initiatives for Promoting Generics
The Indian government is doing full promotion regarding generic medications. The following initiatives are taken by for generics:
Common challenges to overcome
The usual challenges that we need to work on are listed below:
- Regulatory issues: There are weak and improper regulatory criteria for manufacturing generic drugs.
- Branded generics: The price of branded generics is expensive as compared with normal ones. But they also work effectively, like expensive ones.
- Quality: There are some factors that might affect the quality of the generics, such as research, processing, and manufacturing.
- Vitro dissolution: This demonstrates the drug product equivalence in some cases, but the poor regulatory criteria hinder trust in generic medications.
Possible Solution in Generic Medicine in India
Education: The proper knowledge and awareness about the generics can have a significant impact on society. Hence, the use of generics will exponentially increase as well.
Engineering: The production of generics will become more efficient and trustworthy because of quality and efficiency. This will ensure the safety, potency and efficacy of the drugs while manufacturing them.
Economics: Buying more generics can help the buyer save a lot of money, which will also affect the economy.
Enforcement: This ensures proper compliance with regulations, as law enforcement will keep manufacturers and pharmacists in check.
Who Started Generic Medicines in India?
Revolutionary-Initially, the generic drugs were designed to fill the gap of brand name drugs in the market as they are similar in terms of dosage, strength, route of administration, and usage.
After the independence of the country, the pharmaceutical industry foresaw a revolutionary moment in the introduction of many drugs made to treat various therapeutic needs.
With the support of the government and health-related schemes, there was a huge surge in domestic drug production.
The Indian Medical Association (IMA) has called for a “one drug, one quality, one price” system for all generic drug manufacturers to ensure that they meet high standards. Furthermore, government schemes and initiatives have increased awareness and accessibility of generic medications in the country.
Are Generic Medicines Effective in India?
The effectiveness and key features of generic medicines are briefed in the following points:
Challenges facing the Indian pharmaceutical industry
There are specific difficulties faced by the Indian pharmaceutical industry that are listed below in detail, along with a brief explanation.
- Regulatory compliance: The strict rules set by authorities are hard to follow, especially when they get regular updates both domestically and internationally. It is arduous to ensure compliance with good manufacturing practices in this scenario.
- Quality concerns: Maintaining high quality during manufacturing process consistently is a challenge for pharmaceutical companies. Along with that, fighting counterfeit drugs is a problematic issue for the whole market.
- Intellectual property issues: Patents on the formulation of drugs can be a huge hindrance for manufacturing companies. The legal battle becomes more frequent and long-term.
- Infrastructure and logistics: Supply chain management becomes in-efficient due to poor infrastructure and less knowledge about logistics.
- Market competition: With the increasing number of competitors in the pharmaceutical market, it is difficult to cope and lead a successful business.
What standards must generic medicines meet to receive FDA approval?
The following things need to be in check to get approval from the FDA:
Why does a generic drug look different from a brand drug?
According to the rules of U.S. trademark laws, generic drugs should be strictly different from branded drugs. So, the colour and shape of a generic medicine are different from the branded ones.
In some cases, the pill would have a different coating and flavour. But on the brighter side, the appearance and taste do not affect the effectiveness of the drug.