7.1. ACTIVE PHARMACEUTICAL INGREDIENTS
Why in News?
- Department of Pharmaceuticals (DoP) has sought support from other government departments to reduce India’s import dependence on Active Pharmaceutical Ingredients (APIs).
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- Bulk drugs or APIs are the active raw materials used in a drug that give it the therapeutic effect.
- M. Katoch committee was formed to formulate a long-term policy and strategy for promoting domestic manufacture of APIs/bulk drugs in India.
- Recently, Heavy Water Board has signed an agreement with an Indian firm for supply of Heavy Water for development of deuterium labeled compounds, NMR Solvents, d-labeled Active Pharma Ingredients (APIs).
Heavy Water Board (HWB),
- It’s a constituent unit of Industries and Minerals Sector under Department of Atomic Energy.
- It is primarily responsible for production of Heavy Water (Deuterium Oxide-D2O) which is used as a ‘moderator’ and ‘Coolant’ in the nuclear power as well as research reactors.
What is Heavy Water?
- It is a form of water in which the hydrogen in the molecules is partly or wholly replaced by the isotope deuterium.
- Heavy water may be deuterium oxide, D2O or it may be deuterium protium oxide, DHO.
- Heavy water occurs naturally, although it is much less common than regular water.
- Non-nuclear uses: Preservation of Oral Polio Vaccines, for enhancement of biological efficacy,for enhancing life of lubricants, improving mechanical and chemical properties of polymer etc. Check cashcomet.
Difference with normal water:
- High boiling and freezing point
- More density
- High temperature to achieve maximum density
- High pH i.e. more basic in nature
7.2. PRICE CAP ON KNEE IMPLANTS
Why in News?
- Recently, NPPA capped the prices of knee implants, in a move to reduce product prices by as much as 69%. Check bestcancelcompanies.com.
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- The central drug regulator has requested the Union Ministry of Health and Family Welfare to set up a committee to work out ways to bring heart valves, orthopaedic implants and intra ocular (eye) lenses under the National List of Essential Medicines (NLEM).
- In response, US firms have approached the United States Trade Representative (USTR) against the price capping with a request to either suspend or withdraw India’s benefits under Generalised System of Preferences(GSP).
- GSP is a preferential tariff system extended by developed countries to developing countries involving reduced MFN tariffs or duty free entry of exported products of beneficiary country into the donor country.
- MFN status is given by one country to another country with which it is interested in increasing trade. This status gives specific trade advantages such as reduced tariffs. However according to WTO MFN principle, if one country is granted a special favour, the same has to be done for all other WTO members.
National List of Essential Medicines (NLEM)
- NLEM 2015 contains 376 medicines.
- Criteria for inclusion into this list includes public health emergency, cost effective medicine etc.
- Core Committee formed by the Ministry of Health, reviews and revises the medicines in the NLEM
- Once a drug or medical device is included in NLEM, its price can be capped by NPPA
National Pharmaceutical Pricing Authority [NPPA]
- It is an independent body under Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers.
- Its functions are:
- To fix/revise the controlled bulk drugs prices and formulations.
- To enforce prices and availability of themedicines under the Drugs (Prices Control)Order, 1995/2013.
- To recover amounts overcharged by manufacturers for the controlled drugs from the consumers.
- To monitor the prices of decontrolled drugs in order to keep them at reasonable levels.
7.3. DIGITAL THERAPEUTICS OR DIGICEUTICALS
Why in news?
America’s Food and Drug Administration (FDA) has given its approval to some digital therapeutics.
More about Digital therapeutics
- It can broadly be defined as a treatment or therapy that utilizes digital and often Internet-based health technologies to spur changes in patient behavior to treat a medical or psychological condition. It uses methods rooted in cognitive behavioral therapy to spur patients to make lifestyle changes.
- It is often used as a preventive measure for patients who are at risk of developing more serious conditions. For instance, a patient with prediabetes may be prescribed digital therapeutics as a method to change their diet and behavior.
- It can also be used to treat patients with psychological and neurological disorders.
7.4. USE OF PET BOTTLES FOR MEDICINES
Why in news?
- National Institute of Nutrition (NIN) will assess the health impact of the use of polyethylene terephthalate (PET) or plastic bottles to package medicines.
About Polyethylene terephthalate (PET)
- PET is a strong, stiff synthetic fibre and resin, and a member of the polyester family of polymers.
- It is produced by the polymerization of ethylene glycol and terephthalic acid.
A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as theIt is a major industrial polymer and is used for making disposable beverage bottles,photographic film and magnetic recording tape.
- Also made into fibre filling for insulated clothing and for furniture and pillows.
- Industrial applications of PET are automobile tire yarns, conveyor belts and drive belts, reinforcement for fire and garden hoses, seat belts, nonwoven fabrics for stabilizing drainage ditches, culverts, and railroad beds, and disposable medical garments.
National Institute of Nutrition
- The National Institute of Nutrition (NIN), established in 1918 and presently located in Hyderabad, is India’s premier nutrition research institute. It is one of the oldest research centers in India under the Indian Council of Medical
- Mission: To enable food and nutrition security conducive to good health, growth & development and increase productivity, so as to achieve the national nutrition goals as per the national nutrition policy.
- 2018 marks NIN Centenary (1918-2018) Celebrations. It is organising Conference on“Nutrition Before, Beyond and During First 1000 Days of Life – Evidence to Action”
7.5. BIOSIMILAR FOR CANCER
Why in news?
- Recently, Biocon became the first Indian company to get a US Food and Drug Administration (USFDA) nod for a biosimilar drug Ogivri.
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- Ogivri is a biosimilar to Herceptin, used for treatment of breast cancer or stomach cancer and second for cancer.
What are biosimilars?
- A biosimilar medicine is a biological medicine that is developed to be highly similar and clinically equivalent to an existing biological ‘reference medicine’ or ‘originator medicine’.
- They are different from generic medicines, because they contain simpler chemical structures and are identical, in terms of molecular structure, to their reference drugs.
- Development of Biosimilars is challenging as it requires high investment and much longer time as compared to generic drug manufacturing.
- Biological medicines are derived from living cells or organisms.
- These medicines are proteins, such as hormones or antibodies that the human body produces but in certain diseases, their production shuts down or weakens.
- The most important biological medicines are used to treat Diabetes by substituting for the body’s own insulin production Various cancers, difficult skin and joint diseases, asthma etc
7.6. NATIONAL BIOPHARMA MISSION
- Recently, Innovate in India (i3) i.e. the National Biopharma Mission was launched by the government to make India a hub for design and development of novel, affordable and effective biopharmaceutical products and solutions.
About Biopharma mission
- Currently India has only 2.8% share in the global biopharmaceutical market, the program would elevate this to 5% resulting in an additional business opportunity of 16 Billion USD.
- The Mission to be implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology, will bring together expertise from national and international corridors to provide strategic guidance and direction to move promising solutions through the product development value chain.