Generic Drugs from India
Being the largest manufacturer of generic drugs in the world, according to a recent India Brand Equity Foundation study, India supplies 40% of all generic drugs available in the United States. In the UK, Indian generics make up 25% of the entire pharmaceutical market. This article tells about these generics, their quality, efficacy and safety in detail.
History and Current Status of India’s Generic Drugs Industry
Back in 1960s India’s GDP per capita was under $400, so people couldn’t afford expensive patented drugs. The strict patent laws were also stifling the development of pharmaceutical companies, so the government reacted with a much more liberal Patents Act of 1970. The Act limited patent protection to only the process of manufacture of drugs and not the substances themselves. As the result, the largest Indian pharma companies including Sun Pharma, Lupin, Alkem Laboratories and more were incorporated and experienced rapid growth in 1970s and 1980s. They quickly occupied the domestic pharmaceutical market and started expanding internationally. In 1985 Cipla became the first Indian pharma manufacturer to be approved by the US FDA.
The prices of drugs are also heavily regulated by the Indian authorities by means of the Drug Price Control Order. The order ensures that the essential medications remain affordable. According to a 2015 Bloomberg research, medication prices in India are 54% to 98% lower than in the US.
The situation changed in 2005 when India, being a member of the World Trade Organization, had to accept the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which ensures patent coverage of pharmaceutical products. This did not affect the Indian pharmaceutical industry where patented drugs account for only 15% of the export market as much as it affected the consumer. Nowadays the prices of the newest patent-protected medications are high in India as the local companies don’t have the right to produce their generics any longer. Exceptions exist, such as the cases with Bayer and Novartis when Indian companies were allowed to copy patented drugs, but they are few.
Being the world’s third largest producer of medications by volume, , India is also the primary origin of counterfeit medications – up to 75% of them found worldwide, according to a study by Kirsty Barnes. To avoid running into fakes, patients are recommended to buy only from reliable licensed pharmacies and choose only the products of well-reputed manufacturers. The list of India’s largest pharma companies whose high-quality medicines cover the essential therapeutic areas includes the ones below.
|Company Name||Number of Product Registrations||Global Presence & Key Markets||Key Therapeutic Segments|
|SUN PHARMACEUTICAL INDUSTRIES||2,000+||150+ countries (North & South America, Europe, Africa, Pacific Asia, Russia & CIS)||Oncology, Psychiatry, Anti-Infectives, Neurology, Cardiology, Diabetology, Gastroenterology, Ophthalmology, Nephrology, Urology, Dermatology, Gynecology, Orthopedics, Respiratory, Dental and Nutritionals|
|CIPLA INC.||1,500+||80+ countries (North America, Europe, Australia, India, Africa)||Cardiovascular, Children’s Health, Dermatology and Cosmetology, Diabetes, HIV/AIDS, Hepatitis, Infectious Diseases & Critical Care, Malaria, Neurosciences, Oncology, Ophthalmology, Osteoporosis, Respiratory, Urology, Women’s Health|
|CADILA HEALTHCARE (also ZYDUS CADILA)||500+||50+ countries (US, Europe, Mexico, Brazil, Africa, Pacific Asia, India)||Anti-Infectives, Cardiology, Gastroenterology, Respiratory, Gynecology, Pain Management, Dermatology|
|CADILA PHARMACEUTICALS||850+||50+ countries (North & South America, Europe, Japan, Asia, CIS and Africa)||Cardiology, Gastroenterology, Pain Management, Anti-Infectives, Diabetology, Immunology, Ophthalmology, Vitamins|
|DR. REDDY’S LABORATORIES||200+||30+ countries (USA, India, Russia and CIS, Germany, the UK, Venezuela, South Africa, Romania, etc.)||Oncology, Cardiology, Gastroenterology, Diabetology, Dermatology, Pain Management|
|MANKIND PHARMA||1,000+||30+ countries (Asia, Latin America, Africa)||Anti-Infectives, Cardiology, Gastroenterology, Reproductive Health, Dermatology|
|ALKEM LABORATORIES||700+||50+ countries (Australia, Asia, Latin America, CIS, India)||Anti-Infectives, Cardiology, Gastroenterology, Diabetology, Dermatology, Oncology, Osteoporosis, Gynecology, Vitamins & Nutrition|
|CACHET PHARMACEUTICALS (part of Alkem Group)||550+||15 countries (Asia, CIS, Africa, US, Central America)||Antibiotics, NSAIDs, Gastroenterology, Nutrition, Osteoporosis, Gynecology|
|LUPIN PHARMACEUTICALS||N/A||100+ countries (USA, Asia, Africa, Australia, Europe, Mexico and Latin America)||Cardiology, Neurology, Diabetology, Anti-Asthma, Anti-Infectives, Gastroenterology, Oncology|
|TORRENT PHARMACEUTICALS||2,000+||40+ countries (US, Europe, Brazil, India)||Cardiology, Neurology, Anti-Infectives, Gastroenterology, Diabetology, Nephrology, Oncology, Gynecology|
|MACLEODS PHARMACEUTICALS||1,500+||80+ countries (South East Asia, Asia Pacific, Africa, North America, EU & EEA, MENA, Latin America and CIS)||Cardiology, Anti-infectives, Neurology, Respiratory, Dermatology, Oncology, Orthopedics, Osteoporosis, Gastroenterology, Gynecology, Diabetology|
|INTAS PHARMACEUTICALS||900+||80+ countries (North America, Europe, Central & Latin America, Africa, Australia, New Zealand, Asia-Pacific, CIS and MENA countries)||Neurology, Psychiatry, Cardiology, Diabetology, Oncology, Urology, Nephrology, Rheumatology, Gynecology, Infertility, Gastroenterology, Pain Management|
|AUROBINDO PHARMA||300+||150+ countries (globally)||Antibiotics, Anti-Retrovirals, Cardiovascular Products, Central Nervous System Products, Gastroenterologicals, and Anti-Allergics|
|WOCKHARDT||70+||20+ (USA, Europe, Middle East, Africa, Asia, Russia and CIS, Mexico, Brazil)||Anti-infectives, Cardiology, Dermatology, Diabetology, Neurology, Pain Management, Respiratory|
|GLENMARK PHARMACEUTICALS||N/A||80+ (US, Europe, India, Russia, Africa)||Dermatology, Oncology, Respiratory, Pain Management,Autoimmune Disorders Treatment|
Most of the pharma companies listed above have their manufacturing facilities monitored by the FDA and similar authorities, so the quality of their products is at par with that of the top US-based manufacturers. The list above is not comprehensive as it only includes the largest Indian pharma producers. Other reliable local companies include Ajanta Pharma, Divis Laboratories, Jubilant Life Sciences, Piramal Enterprises, Ipca Laboratories, Alembic Pharmaceuticals, Biocon, Natco Pharma, Laurus Labs, Nectar Lifesciences and more.
Pros and Cons of Indian Generics
The benefits of generic drugs from India are listed below.
- They work.Generic drugs are bioequivalent to their brand-name alternatives. It means that they deliver as much active substance in the same amount of time and to the same site in the patient’s body as the branded drug. The bioequivalence of generic drugs is verified by the FDA before they are approved and allowed into the market.
- They are cheap. Generic drugs generated more than $200 billion in savings in 2017 in the US alone. Accounting for 90% of the prescriptions, they were responsible for only 23% of the money spent on pharmaceuticals, as this study by the AJMC shows.
- They make branded drugs’ prices go down. On a larger scale, the wide availability and popularity of generic medications makes branded firms reduce the prices of their products.
The main drawback of generic drugs from India is the fact that it’s difficult to tell a high-quality medication from a counterfeit one, especially when the patient is taking this medication for the first time. To avoid fakes, follow these recommendations:
- Buy medications only from trusted sources, preferably from licensed pharmacies;
- Choose medications by reliable manufacturers;
- Pay attention to the appearance of the medication – if it smells or tastes strange, or the pills crumble easily, it’s better to avoid it;
- Pay attention to the medication packaging – grammar mistakes in the text, print flaws, absence of expiry dates are all signs of a fake;
- Keep a diary of the medication’s effects and adverse reactions.
Myths About Generic Drugs from India
There are two common misconceptions concerning generic drugs from India:
Myth #1: Generics contain the active ingredients in wrong amounts. The people advocating this point of view refer to the ANDA specifications allowing a 20% variation in key efficacy parameters of bioequivalent drugs. They assume a generic may contain 80% to 125% of the active ingredient that is present in the branded drug. A study by C Andrade proves that the possible variations between the generic and its branded alternative are much smaller due to the multi-factor nature of the comparison.
Generics’ supposedly inferior efficacy compared to that of brand-name drugs has been reported by multiple patients –like inthe comments to this podcast, for example. In vitro researches including the one by Priyanka Pathak and Jayshree Dawane prove otherwise – generics and brand-name drugs are equally effective.
Myth #2: Different excipients alter the way the active ingredient works. For example, extended release brand-name drugs break down in the digestive system slowly, gradually delivering the active substance into the patient’s system. If a generic formulation doesn’t follow this pattern and releases the active ingredient too quickly, it results in compromised efficacy or increased risk of side effects. However, this can’t happen if the generic is bioequivalent to the branded medication and it is verified by the FDA or another controlling authority following the same procedures. All FDA-approved generics guarantee that the active ingredient is delivered into its site of action at the same rate and to the same extent as with the branded drug.
How to Buy Indian Generics
The process of purchasing a generic medication by an Indian manufacturer depends on whether it is approved in the patient’s country or not.
- Buying approved generics is the same with buying branded pills. First, the patient gets a prescription from their doctor and then fills it at a pharmacy of their choice. Over-the-counter generic medications do not require a prescription.
- Unapproved generics can either be ordered online from a foreign pharmacy located in the country where this generic is legal or purchased in person during a trip abroad. It is important to check the following prior to buying:
- The prescription status of the medication in the country one is buying from. If it requires a prescription, the papers from the patient’s local doctorneed to be verified by a licensed healthcare provider or pharmacist in the country they are purchasing from.
- Is the medication allowed for import into the patient’s country? For example, Japan doesn’t allow the imports of medications containing pseudoephedrine, such as Allrite-D or Loridin-D by Zydus, or codeine.
Most countries including the US, UK, Australia, etc. allow or, at least, choose not to intercept the imports of unapproved generics intended for personal use and shipped in small amounts – 1-3-months’ worth, depending on the country.
India’s generic pharmaceuticals industry is very strong with over 1,000 companies making up the Indian Drug Manufacturers’ Association already. The generics produced by the largest Indian companies are highly reliable and as effective as their brand-name counterparts. However, 75% of the world’s counterfeit medications also originate from India, so it’s important to choose one’s drugs carefully. If the medication comes from a trustworthy manufacturer and retailer, it can be used as a replacement of a brand-name one in all patients.
- Overview of the Indian pharmaceutical market by India Brand Equity Foundation, 2018 - https://www.ibef.org/industry/pharmaceutical-india.aspx
- History of GDP in India, 1960s to now - https://tradingeconomics.com/india/gdp-per-capita
- Indian Patents Act of 1970 - https://wipolex.wipo.int/en/text/128092
- Top pharmaceutical companies in India - https://www.wirc-icai.org/material/Capital-Markets.pdf
- Cipla gets approved by the US FDA in 1985 - https://www.cipla.com/en/our-businesses/geographies/north-america.html
- Drug Price Control Order, a means of keeping medicine prices low in India - http://www.arthapedia.in/index.php?title=Drug_Price_Control_Orders_(DPCO)
- Bloomberg, comparison of drug prices around the world - https://www.bloomberg.com/graphics/2015-drug-prices/
- N Dubey et al, Indian pharmaceutical industry pre- and post-TRIPS - https://www.researchgate.net/publication/265181276_Performance_of_the_Indian_Pharmaceutical_Industry_Pre_and_Post_TRIPS_Era_A_Study
- Indian government allowed local companies to copy a patent-protected cancer drug by Bayer and a medication by Novartis - http://www.businessworld.in/article/India-Emerges-As-Top-Five-Pharmaceuticals-Markets-Of-The-World/05-05-2018-148349/
- K Barnes, Counterfeit pharmaceutical market trends - https://www.outsourcing-pharma.com/Article/2007/11/07/New-counterfeit-report-highlights-worrying-trends?n=81178-oecd-counterfeit-drug-supply-chain
- Largest pharma companies in India, by sales - https://www.moneycontrol.com/stocks/marketinfo/netsales/bse/pharmaceuticals.html
- Overview of generic drug approval process by the FDA - https://www.fda.gov/downloads/forpatients/about/ucm410215.pdf
- Generics generate over $200 billion is savings in the US - https://www.ajmc.com/newsroom/generics-generated-over-200-billion-in-savings-in-2017
- Pros and cons of generic drugs podcast, The People’s Pharmacy - https://www.peoplespharmacy.com/2014/12/11/show-973-the-pros-and-cons-of-generic-drugs/
- P Pathak, J Dawane, Comparison of generic and branded versions of Amoxicillin with Potassium Clavulanate - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071957/
- Certain medications including over-the-counter ones are illegal to import into Japan - http://www.associatedkyotoprogram.org/bringing-medications-japan/
- FDA’s policy regarding importing medications for personal use and current situation in the market - https://www.webmd.com/healthy-aging/features/letter-and-spirit-of-drug-import-laws#3
- About the Indian Drug Manufacturer’s Association - https://www.idma-assn.org/about-idma.html