Chemical Engineering
09 January 2023 12:42
Future of EV
Replacement of Lithium in EV vehicles ?
Sensors in cars and China ?
API 1. API – India imports 70% of bulk drugs from China. 2018-19 imported worth 2.4 billion $. API is the material that produces intended
efforts to cure the disease. API for crocin – paracetamol. API for pain relief medicines – acetaminophen. Two ingredients of drugs – API
(chemically active) and Chemically inactive, Excipients. API is not formed by one raw material via one reaction, rather via several
compounds, raw material for API is called intermediate. Long manufacturing process until it is purified and reached high purity. Quality
of API is crucial.
a. During early 90s India was self reliant in APIs. CPCB identified API sector as 18 most polluting industry and coz of strict rules and
regulations, setup of API industry became difficult. Eventually China started selling cheaper APIs and captured market and further
achieved economies of scale. 40% cheaper than Indian apis in 90s. But now rising labor cost, only 20% cheaper than indian apis.
China created low cost API mfg industry – by low cost of capital, aggressive govt funding, tax incentives. Cost of ops – 1/4th.
Importing APIs became chepaer for India pharma. APIs – ascorbic acid (vit C), Aspartame (sweetnesers), rifampicine. Ultimately
india stopped producing APIs as well as intermediates.
Associated Term :
‘Hollowing out’ refers to deterioration of a country’s manufacturing sector when producers move important activities of manufacturing
to low-cost facilities overseas (China producing API at 40% cheaper rate than that of Indian manufacturer).
IPR and India In India, patents are governed by the Patents Act, 1970. Under the act, patents are granted if the invention fulfils the following
criteria: (a) It should be novel; (b) It should have inventive step/s or it must be non-obvious; (c) It should be capable of Industrial
application; (d) It should not attract the provisions of sections 3 and 4 of the Patents Act 1970.
India has gradually aligned itself with international regimes pertaining to intellectual property rights. It became a party to the Trade-
Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organization on January 1,
1995. Following this, India amended its internal patent laws to comply with TRIPS, most notably in 2005, when it introduced
pharmaceutical product patents into the legislation.
India has been ranked 40th out of 53 countries on the Global Intellectual Property Index. India’s score increased from 36.04% (16.22 out of
45) in 2019 to 38.46% (19.23 out of 50) in 2020.
IP laws are required to promote innovation in the R&D of new medicine or vaccines. However, it is due to these IPRs laws only, the global
pharmaceutical industry establishes a monopoly over life-saving drugs.
Way Forward: Intellectual Production without Intellectual Protection
1. Leveraging Global Forums :
a. Coalition for Epidemic Preparedness Innovations (CEPI) is supported by a World Bank financial intermediary fund that brings
together public, philanthropic, and private funding to respond to global priorities.
2. Establishing Patent Pool :
a. Through the Medicines Patent Pool, the United Nations and the WHO have for years sought to increase access to treatments
for HIV/AIDS, hepatitis C, and tuberculosis.
b. Patent pools, prize funds, and other similar ideas are part of a broader agenda to reform how life-saving drugs are developed
and made available.
3. Vaccine Bonds
Compulsory Licensing • Compulsory Licensing (CL) allows governments to license third parties (that is, parties other than the patent holders) to produce and
market a patented product or process without the consent of patent owners.
• Any time after three years from date of sealing of a patent, application for compulsory license can be made, provided:
• reasonable requirements of public have not been satisfied;
• patented invention is not available to public at a reasonably affordable price;
• Patented invention is not worked in India.
It is TRIPS compliant
India as Pharmacy to the World • India is the largest provider of generic drugs globally.
• The Indian pharmaceutical industry meets over 50% of global demand for various vaccines, 40% of generic demand in the U.S. and 25% of
all medicine in the U.K.
• Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by
Indian pharmaceutical firms.
• India has one of the lowest manufacturing costs in the world – lower than that of the U.S. and almost half of the cost in Europe.
Evergreening in India Mentioned under Section 3(d) of Indian Patent Act, 1970
• Section 3(d) of Indian Patent Act prevents the “ever-greening” of patents.
• It means that the following inventions are not patentable:
• mere discovery of a new form of a known substance and which does not result in increased efficacy of that substance.
• mere discovery of any new property.
• new use for a known substance.
• mere use of a known process, machine or apparatus unless such process results in a new product.
• This, in other words meant that India did not support inventions which were minor modifications and thus prevented undue monopoly
during the extended period of patent protection by the inventor/company.
Biosimilars vs Generic vs Biologics
Biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent
expires. Biosimilars are the generic versions of biologics medicines made from animal or plant proteins as opposed to chemicals.
Difference between biosimilars and generics:
1. Biosimilars involve developing equivalent of biological entity while generics involve developing equivalent of a chemical entity-the
Active Pharmaceutical Ingredient.
2. In case of biosimilars, biological entities being some ward different (and not as it is of replica), every organism has to be engineered
to produce the same therapeutic effect while in generics, the copies of API can be generated
3. Bio-similars differ from generics – in complexity, in the manufacturing processes and in the data needed to demonstrate similarity
for approval. The structure of Generic Simple and well-defined whereas for Bio-similar its Complex with potential structural
variations.
4. Regulatory procedure to get approval for biosimilars is complex as compared to that of a generic.
Jan Aushadhi Diwas 5th Edition this year
Generate awareness about the usages of generic medicines and benefits of Jan Aushadhi Pariyojana.
What is Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)?
1. PMBJP is a campaign launched by the Department of Pharmaceuticals in 2008 under the name Jan Aushadhi Campaign.
2. The campaign was revamped as PMBJP in 2015-16.
3. Bureau of Pharma PSUs of India (BPPI) under the Ministry of Chemicals & Fertilisers is the implementation agency for PMBJP.
4. BPPI has also developed the Janaushadhi Sugam Application.
5. A medicine is priced on the principle of maximum 50% of average price of the top three brands branded medicines. Thus, the prices
of Jan Aushadhi Medicines are cheaper by at least 50% and in some cases, by 80% to 90% of the market price of the branded
medicines.
What is the objective of the PMBJP?
1. Available quality medicines, consumables and surgical items at affordable prices for all
2. Popularise generic medicines among the masses
3. Ensure easy availability of the menstrual health services (Janaushadhi ‘Suvidha’ sanitary napkins) to all women across India.
4. Employment by engaging individual entrepreneurs in the opening of PMBJP Kendras.
(Till 31st January, 2022), PMBI has made sales of Rs. 751.42 Crore which led to savings of approximately Rs. 4500 Crore to the citizens.
