India is growing as one of the biggest economy of the world. The Pharmaceutical Industry in India is one of the largest in the world and it ranks 4th in the world, pertaining to the volume of sales. As per report of India Brand Equity foundation, India's domestic pharmaceutical market turnover reached Rs 129,015 crore (US$ 18.12 billion) in 2018, growing 9.4 percent since 2017. In the world, India is the largest provider of generic medicines. It supplies over 50 percent of global demand for various vaccines, 40 percent of generic demand in the US and 25 percent of all medicine in UK. Even India is supplying around 80% of anti-HIV medicines across the globe.
The pharmaceutical is one of the most regulated industries across the globe. But when it comes to regulation in indigenous companies, we are starting to assume that Indian regulators are not taking stringent steps towards quality and affordability of medicines. Straightly, we are starting to compare ourselves with foreign regulators, especially USFDA. No doubt USFDA is one of the best regulators in the world and obviously it is not wrong to compare or to dream about reaching at that mark. But let me remind you that our country has different level of difficulties or problems while providing essential medications to whole populations. We have many other problems like poverty, growing populations, employment, industry level education etc. In spite of that CDSCO is able to control quality of medications from local industries.
Addressing the 70th Indian Pharmaceutical Congress at Amity University, Noida Shri M. Venkaiah Naidu, the Vice President of India, said that India becoming the largest provider of generic drugs globally with the Indian generics accounting for 20 % of global exports in terms of volume was an eloquent testimony to the competence of the Indian pharma sector in terms of quality and pricing.
In US, a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. It works in the same way and provides the same clinical benefits as its brand-name version. Approved generic medicines are generally sold only after patents and exclusivities protecting the brand-name version end. Unlike in India, generic medicines concept is different and general population have various opinions. We have two types of generic medicines – one is costly and said to be quality medicine and another is affordable and some people think or say it to be of lesser quality medicine.
Well, it is not !
One person is prescribed with metoprolol’s brand worth Rs. 250 for 10 tablets and same medicine is available with different brand name worth Rs.35 for 10 tablets. And both brands are from reputed pharmaceutical companies. Then which brand should be preferred?
Low price doesn’t reflects lower quality of medicine. As a pharmacist, we know that both brands will exhibit same effects. There are many examples nearby our society, which shows stable patient condition when such brands are altered. But problem is that no such bigger scale clinical studies available which verifies it in India. Though, Desai RJ published an article in reputed journal, PLoS Medicine in March 2019 which he clearly concluded comparable clinical outcomes of generic medicines against use of brand-name products in USA.
But when it comes to quality of Government’s Jan Aushadhi Kendras, again question started to raise on these medicines. There are more than 700 medicines; more than 150 surgical and consumables are available at affordable prices for all at more than 4000 ‘Jan Aushadi Kendras’ across the nation. But as per study conducted by Singhal G.L., Kotwani Anita and Nanda Arun the medicines which were tested after procuring from Jan Aushadhi sources are of equivalent and comparable quality to their counterpart branded medicines available in the market which was limited to few medicines only. They also published their study in International Journal of Pharmacy and Pharmaceutical Sciences in 2011. This article can also be retrieved from WHO website.
Government should concentrate on publishing more clinical studies on quality and behaviour of these generic medicines.
Rajesh Vagh
PharmaTutor Edu Labs
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