Generic Medicines: An Indian Perspective

By Dr. Sachin Singh | 31st Oct 2022

Generic Medicines: An Indian Perspective

Generic Medicines: an  Overview

A generic drug is a medicine that is made to be the same as a brand-name drug already on the market in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and the way it is meant to be used. These similarities help show bioequivalence, which means that a generic medicine works the same way as brand-name medicine and gives the same clinical benefit.

In other words, you can take a generic version of a brand-name(branded) drug as a substitute for a branded drug. When a branded medicine is initially developed, the firm that created it submits an application for a patent. This patent has a lifespan of a specified number of years, after which the company that created it has the opportunity to recuperate the cost of the research investment.

After a branded medicine’s patent has run its course and expired, the medicine can then be made as a generic medicine if the manufacturer first receives approval, and then complies with quality and safety standards. These items may be produced by the same company as well as by other businesses.

India: Pharmacy of the World 

India is the biggest supplier of generic drugs in the world. It is known for its cheap vaccines and generic drugs, which make up 20% of the global supply by volume. The Indian pharmaceutical industry is currently third in terms of the amount of medicine it makes. Some of the most important parts of the Indian pharmaceutical industry are generic drugs, over-the-counter drugs, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. India has the most US Food and Drug Administration (USFDA)-compliant pharmaceutical manufacturing facilities. It also has 500 API producers, which make up about 8% of the worldwide API market.

According to Shri DV Sadananda Gowda, the Union Minister for Chemicals and Fertilisers, India is one of the largest makers and exporters of generic medications in the entire globe. He emphasised that because India is a trustworthy supplier of medicines to more than 120 countries around the world, India has earned the reputation of being a trusted supplier of medicines. 

In the field of global pharmaceuticals, India holds a significant and influential position. At the moment, Indian pharmaceutical companies are the source of more than 80 per cent of the antiretroviral medications that are being utilised all over the world to fight against AIDS (Acquired Immune Deficiency Syndrome). Because of the exceptionally low prices and high standards of India’s pharmaceutical products, the country is widely regarded as the “pharmacy of the world.”

Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ – A Step Towards Generic Medicine:

Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana’(PMBJP) programme, which was initiated by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers, Government of India, high-quality generic medicines are made available for purchase all over the nation at Pradhan Mantri Bhartiya Janaushadhi Kendras, which are specifically designated outlets (PMBJK). As of the 10th of March 2021, a total of 7507 PMBJKs have been established around the nation.

Also, all drugs made in the country, whether they are generic or brand-name, must meet the same quality standards set out in the Drugs and Cosmetics Act of 1940 and the Rules made under it in 1945. Because of this, we expect them to have the same effects. Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 says that every doctor should write the generic names of drugs clearly and, if possible, in capital letters. He or she should also make sure that drugs are prescribed and used in a reasonable way. 

The Ministry of Health and Family Welfare has also taken a number of regulatory steps to promote generic medicines and make sure their quality. These include telling Licensing Authorities to give or renew licences to make drugs for sale or distribution in their proper or generic names only, changing the Drugs and Cosmetics Rules of 1945 to make it mandatory to give a licence for a drug formulation with a single active ingredient in its proper name, and adding a rule to the Rules of 1945 that says the result of a bioequivalence study must be submitted with the application for a licence to make drugs.

The final takeaway of the Jan Aushadhi campaign

  • One of the main goals of the Jan Aushadhi campaign is to make sure that everyone can get low-cost, high-quality medicines through special stores.
  • Reduce the cost of treatment for each person, especially those with long-term illnesses.
  • Make people aware through education and publicity that a high price doesn’t always mean a drug is effective and strong.
  • Make people want low-cost generic medicines
  • Get doctors to write prescriptions for generic drugs

Conclusion:

In the current environment, generic drugs seem to be the greatest alternative for India; nevertheless, the mindset of the average Indian needs to undergo significant shifts before they can accept the generic form of medication. In addition to this, there is a larger demand for standardised medication regulation around the globe in order to facilitate overall expansion in the pharmaceutical industry. 

In order to deduce a broad picture relevant to attitudes toward generic medicine prescribing, survey studies that are well organised and specifically take into consideration patients, community pharmacists, and physicians should be planned. 

However, we at Truemeds (an online pharmacy store) have paved the way to disburse generic medicines. We provide home delivery, a discount, or monthly savings on your bill. If the pharmacy shop doesn’t have the medicines you need we help you buy generic medicine online and save up to 72% and get it sent to your home for free across India. We also offer teleconsultations and other consumer health products. We are one of the most trusted and well-known online stores for generic medicines. 

References:

  1. Pharmaceutical Companies in India, Indian Pharma Industry- IBEF
  2. Pharma industry in India: Invest in Indian Pharma Sector (investindia.gov.in)
  3. Generic Drugs: Questions & Answers | FDA
  4. 80% drugs to combat AIDS globally supplied by India: Health minister | Business Standard News (business-standard.com)
  5. English Annual Report 2020-21.pdf (pharmaceuticals.gov.in)
  6. https://www.pib.gov.in/PressReleasePage.aspx?PRID=1705065
  7. 4FoldBrochure.pdf (janaushadhi.gov.in)

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