send mail to support@abhimanu.com mentioning your email id and mobileno registered with us! if details not recieved
Resend Opt after 60 Sec.
By Loging in you agree to Terms of Services and Privacy Policy
Please specify
Please verify your mobile number
Login not allowed, Please logout from existing browser
Please update your name
Subscribe to Notifications
Stay updated with the latest Current affairs and other important updates regarding video Lectures, Test Schedules, live sessions etc..
Your Free user account at abhipedia has been created.
Remember, success is a journey, not a destination. Stay motivated and keep moving forward!
Refer & Earn
Enquire Now
My Abhipedia Earning
Kindly Login to view your earning
Support
Background:
Accessible and affordable medicines are of utmost importance for any needy patient. In a developing country like India and many of its counterparts, generic drugs will be the panacea. India’s rejections for ‘secondary patents’ are commendable.
Introduction:
India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. Of late, consolidation has become an important characteristic of the Indian pharmaceutical market as the industry is highly fragmented.
India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immuno Deficiency Syndrome) are supplied by Indian pharmaceutical firms.
R&D on Pharmaceutical Industry:
Pharmaceutical R&D is an expensive, time consuming and uncertain process that may take many years to complete. The useful new drugs are patented, protecting them from competition and allowing them to charge high prices. When the patent ends, other companies are allowed to supply the previously patented drug. These are known as generics. The prices of generic drugs are much lower than the prices of in-patent drugs.
However, Pharmaceutical companies through ever-greening continue to seek extra patents on variations of the original drug. Such is the case with the world’s best-selling prescription drug, Humira, continue to grow even after the expiry of the patent over its main ingredient, adalimumab, and a biologic used for the treatment of arthritis by Secondary Patents.
The U.S. recognises and encourages secondary patents. India, however, does not. India’s rejection of secondary patents has kept blockbuster medicines affordable for many.
How does ever-greening works?
Patents offer their owners market exclusivity for a limited period of time. For medicines, this exclusivity should last as long as the primary patent — which relates to the active pharmaceutical ingredient (API) of the medicine is in effect, typically 20 years. The end of patent exclusivity will reduce the drug prices drastically.
However, pharmaceutical companies find new ways to postpone their exclusivity by filing secondary patents making small changes to an original drug with a new formulation, a dosage regimen, or a new method of administering the medicine. This practice is called ever-greening.
Ever-greening of drugs is not accepted in India:
Indian Patent Act:
Major innovations in Indian patent law:
Evergreening Rampant in India?
Innovators instead seek to reset the 20-year clock by subsequently filing patents that are minor variants of the parent compound, called secondary patents. This practice, known as evergreening, allows a prolonged monopoly that unfairly denies the public access to medicines at equitable prices. Such variants to previously known drugs are usually arrived at as a manner of routine experimentation in the pharmaceutical sciences, and hence may not be truly innovative. Despite such measures, we discovered that evergreening practices may be rampant in India, based on a study of about 2,300 patents for drugs granted between 2009 and 2016. In our study titled Pharmaceutical Patent Grants In India, have been shown that the IPO could be operating with an error rate as high as 72% for secondary patents, despite provisions to keep them in check. The argument pharma companies had against Section 3(d) was that it would affect the incentive to innovate. What has been demonstrated in the cases under study, is that by overcoming Section 3(d) they only have an incentive to tweak and not innovate.
Recently Conducted INDIA PHARMA in FEBRUARY, 2018:
How to boost public sector drug manufacturing :-
1. India needs to develop both public and private sector capacity within the country, with suitable government support and incentives, to ensure uninterrupted and inexpensive availability of APIs.
2. The High Level Expert Group Report on Universal Health Coverage for India (2011) clearly articulated the need for strengthening public sector units (PSUs) because:- The use of PSUs will offer an opportunity to produce drug volumes for use in primary and secondary care facilities as well as help in ‘benchmarking’ drug costs. Effective implementation of the Ayushman Bharat initiative calls for investment in expanding public sector capacity for producing essential drugs and APIs. The UN report also urges member states of WTO to adopt a permanent revision of Paragraph 6 of the TRIPS agreement to enable swift and expeditious export of pharmaceutical products produced under compulsory license. India should take the lead in ensuring universal access to affordable drugs through such measures.
3. National Biopharma mission needs effective implementation:- Innovate in India(i3) will witness an investment of USD 250 million with USD 125 million as a loan from world Bank and is anticipated to be a game changer for the Indian Biopharmaceutical industry. It aspires to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector.
Road Ahead:
1. The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others. Pharma sector’s revenues are expected to grow by 9 per cent year-on-year through fiscal 2020.
2. Ayushman Bharat health insurance scheme announced by the Government, popularly called as ‘Namo-Care’, has the potential to turn India into the largest pharma manufacturer of the world in about three years
3. Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.
4. The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.
5. Investment in public sector capacity is essential to ensure that the country can exercise that leadership even on occasions when the private pharmaceutical sector does not fully align with that objective.
6. There was an immediate need felt to focus on consolidated efforts to promote product discovery, translational research and early stage manufacturing in the country to ensure inclusive innovation.
By: Priyank Kishore ProfileResourcesReport error
Access to prime resources