Generic Drugs

Facts:
  • India ranks fourth in pharmaceutical production in the world.
  • It has a 1.4 per cent share by value and 10 per cent by volume in the global pharma industry.
  • India, one of the leaders in pharmaceutical exports, exports drugs worldwide to more than 200 countries. The U.S. is single largest export destination. The pharma exports to the U.S. market are high due to the large number of approvals from the USFDA.
  • Generic drugs account for 75 per cent of the domestic pharmaceutical market by value.
Recent Steps:
  • With key initiatives announced by Modi Government to include price control policies and the revision of Jan Aushadhi campaign, the market is likely to show a notable incline in the penetration of unbranded drugs.
  • The influence of physicians in India in terms of prescribing branded medicines and the lack of drug pricing control laws have limited the consumption of unbranded generics in the domestic market.
What are Generic Drugs?
  • The brand producing a new molecule gets a patent to be able to have selling rights.
  • Once a drug loses its patent protection, it can then be produced by several other drug manufacturers and is called a ‘generic’.
  • A generic drug is defined as a drug product that is comparable to a brand/reference-listed drug product in dosage, strength, route of administration, quality and performance characteristics and intended use.
  • Branded generics are those that are given a unique name by their marketers to enable doctors and patients to identify a product they can trust from the ocean of numerous alternatives.
 
What is Jan Aushadhi Store?
The Government, in June 2015, had proposed to open 1000 more stores under the ‘Jan Aushadhi Scheme’ to make available quality generic medicines at affordable prices through these special outlets.
It is a scheme which seeks to make available quality medicines at affordable prices for all, especially the poor and the disadvantaged
  • Under this, less priced quality unbranded generic medicines will be made available through Jan Aushadhi stores which inherently are less priced but are of same and equivalent quality, efficacy and safety as compared to branded generic medicines.
  • Under this Scheme, the State Government has to provide space in Government Hospital premises for the running of the outlets (JAS). Government hospitals, NGOs, Charitable Organisations and public societies like Red Cross Society, Rogi Kalyan Samiti typically constituted for the purpose can be operating agencies for the JAS.
  • The State Government has to ensure prescription of unbranded generic medicines by the Government doctors
  • The BPPI is responsible for implementing the Jan Aushadhi programme which was launched in 2008
 
What is BPPI?
BPPI (Bureau of Pharma Public Sector Undertakings of India) has been established under the Department of Pharmaceuticals, Govt. of India, with the support of all the CPSUs for co-coordinating procurement, supply and marketing of generic drugs through the Jan Aushadhi Stores
 
Concerns related to Generic Drugs:
  • Though efforts have been made to draw the government’s attention to the substandard quality of some generic drugs floating across the country there is still no clarity on the definitions of all three categories.
  • The confusion is not just limited to laypersons but is prevalent among doctors too.
  • The government’s decision to ask doctors to prescribe a generic name has made things complicated.
  • Current regulations allow doctors to prescribe branded as well as generic drugs but generic drugs can also be produced by brands (branded generic).
  • Even the chemists do not have a way to know about the differences in quality as patients do not come back and inform them about their recovery.
 
Way forward
  • There is a need to have in place stringent criteria for government agencies to ensure that there is no difference in the dose, efficacy, potency and side-effects between generics and the branded ones.
  • The government should ensure that all pharmacies have qualified pharmacists and that basic quality is maintained for all generics produced in India.
  • In short, there should be a sort of star-rating for quality certification, helping people to understand the quality of the generic.
  • The government’s intention to promote generics will reach its goal only if these three important factors (clarity in definition, safe quality and standardised quality certifications along with qualification of pharmacists) are considered.
 
 
The central government has taken an initiative ‘Jan Aushadhi‘ to avail citizens of low cost medicines. What will be the benefits of the scheme to the people and the pharmaceutical companies? Critically examine. (200 Words)
 
The Centre will procure medicines in bulk from public as well as private drug manufacturing firms and rebrand them under ‘Jan Aushadhi’. These will be sold in the retail market at a competitive price, allowing consumers to buy a cheaper yet quality product from the government.
 
To start with, the government has identified 504 essential medicines, which include antibiotics, painkillers, vitamins and medicines used in treatment of cardiovascular, respiratory, diabetes and gastroenterology diseases. “In the first phase, we have mostly identified medicines from the top 100 drugs based on their sales. More medicines as well as medical devices will be included in the second phase,
 
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It is said that India is becoming home to production and trial of substandard drugs in recent years. In your opinion, why such drugs are produced and distributed? How can they be regulated? Critically comment. (200 Words)
 
Menace of substandard drugs is highlighted by CAG in case of CGHS and Army Depots.
 
Reasons:
  1. Lack of awareness amongst masses who resort to self-medication, over the counter sale, online sale of drugs, etc. For example Swine Flu mistaken as Common Cold.
  2. Lack of research and development and investment as foreign companies are at loggerheads with Indian IPR laws on ever greening and Compulsory Licensing.
  3. Lenient penalty and imprisonments for illegal approvals and sales of drugs is not much of a deterrent.
  4. State wise different rules and lack of training, labs and quality inspectors for inspecting quality.
  5. Exploitation of uninformed poor people as guinea pigs by vested corporate interests.
 
Measures:
  1. Centralised licensing regime with clear rules for revocation and punitive actions in case of any breach.
  2. Drug quality testing laboratory and infrastructure and complemented by self-certification by manufacturers.
  3. Banning over the counter sale and online sale.
  4. Grievance redressal by modern ICT means for victims of counterfeit drugs.
  5. Attracting foreign investments in phases in different segments of the market.
  6. Mandatory quality checks as suggested by various committees, under Jan Aushadhi program.