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Generic Medicines UPSC NOTE

 


What are generic medicines?

  • Generic medicines can be defined as affordable versions of branded drugs which are brought into the market once the original drug manufacturer’s patent expires.

  • These medicines have the same potency, quality, and implications and work in an identical manner as the branded drug. 

  • The generic medicines are marketed either by a salt or brand name.

  • It will help the patient with the cheapest available generic drug and thus save them the cost of the more expensive branded drugs.

Issues associated with it

Quality of generic medicines: bioequivalence.

  • India has lagged behind countries like the U.S. in creating the appropriate legal and scientific standards that provide guarantees to doctors on the interchangeability of generic medicines with each other and the innovator drug.

  • Most, but not all, generic drugs be tested on human volunteers in order to measure the rate at which the drug is bioavailable; i.e. the rate at which the drug dissolves in the bloodstream. 

  • Such testing is required because generic manufacturers may use different excipients like binders, coating and punching machines which directly affect the ability of the drug to dissolve in the blood. 

  • If the dissolution profile of the generic drug is same or similar to that of the innovator drug over a time period, it is declared to be “bioequivalent” and hence therapeutically interchangeable with the innovator drug.

  • India mandated such bio-equivalence testing only in 2017. Even then, the regulations were vague.

  • A recommendation by the Drugs Technical Advisory Board (DTAB) to ensure that existing generic drugs, approved prior to 2017, also be tested for bioequivalence, was ignored by the government. 

  • This means that a vast majority of drugs in the Indian market have never been tested for bioequivalence.

Quality of generic medicines: stability testing

  • The key challenge to manufacturing any drug is to ensure that it remains stable through a stressed supply chain in differing conditions of heat and humidity. 

  • An unstable drug will start decomposing, possibly reducing its efficacy. 

  • Sometimes a tablet will just crumble into powder when removed from its packaging. 

  • In other instances, the tablet will be visibly discoloured or if it is a liquid, particulate matter may be visible. 

  • Many of these problems can be checked if the law prescribed mandatory stability testing prior to providing marketing approval and also while the drug is in the market.

  • This common requirement across the world became mandatory in India only in 2018, after the government managed to overcome immense opposition from the pharmaceutical industry. 

  • But once again, the new regulations not only lacked scientific rigour, but also did not apply retrospectively to generic drugs approved prior to 2018. 

  • This means that many generic medicines in the Indian market have not been subjected to mandatory stability testing. 


NIRF Rankings 2023

NIRF Rankings 2023 of higher education institutions

  • The National Institutional Ranking Framework (NIRF), under the Union Education Ministry, announced the India Rankings 2023 of higher education institutions.

  • Best educational institution in overall ranking- Indian Institute of Technology (IIT), Madras (fifth consecutive term).

    • Second best - The Indian Institute of Science, Bengaluru.

    • Third best - Indian Institute of Technology, Delhi 

  • Best engineering college - Indian Institute of Technology (IIT), Madras (eighth consecutive term).

  • Best university in the country - Indian Institute of Science, Bengaluru (eight years in a row).

    • Second best - Jawaharlal Nehru University

    • Third best - Jamia Millia Islamia 

  • Best college - Miranda House, Delhi 

    • Colleges in Delhi maintained their dominance in the ranking of colleges with five colleges out of the first 10 colleges from Delhi.

    • Second best - Hindu College, Delhi

    • Third best - Presidency College, Chennai.

  • Top management institute - Indian Institute of Management, Ahmedabad.

    • Second best - IIM Bangalore 

    • Third best - IIM Kozhikode 

  • The National Institute of Pharmaceutical Education and Research, Hyderabad was named the best institute in the field.

    • For the first time, pushing Jamia Hamdard to the second slot.

  • Best medical college - All India Institute of Medical Sciences, Delhi.

    • Second best - Postgraduate Institute of Medical Education and Research, Chandigarh.

    • Third best - Christian Medical College, Vellore.

  • Top dental college - Saveetha Institute of Medical and Technical Sciences, Chennai.

  • Best law college - The National Law School of India University, Bengaluru (sixth consecutive year).

  • Research institutions category - Indian Institute of Science, Bengaluru (third consecutive year).

  • Architecture - IIT-Roorkee

  • Agriculture and allied sectors - Indian Agricultural Research Institute, New Delhi.

  • Innovation category - Indian Institute of Technology, Kanpur.

Parameters identified in the NIRF

  • Teaching, learning and resources, research and professional practice, graduation outcome, outreach and inclusivity, and perception.

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