What are the components of a drug?

  1. Any drug is composed of two components or aspects.
  2. The first is the actual Active Pharmaceutical Ingredients (API), which is the central ingredient.
  3. The API is the chemically active substance, which is meant to produce the desired effect in the body.
  4. The second is known as an excipient, which are the inactive or inert substances present inside a drug.

Indian drug firms will face challenges in U.S.

  1. News: According to ICRA, Indian pharma companies will face a number of challenges in the U.S. market
  2. Background: Indian pharma sector registered strong growth, driven mainly by the US market, on account of large brands going off patent
  3. Challenges: Reduced no. of big products going off patent, increased competition and rise in regulatory scrutiny
  4. Impact: The growth from US market has now come down from high double digits to 8-10%

Learn about Fixed dose combinations (FDC)

  1. FDCs are formed by combining 2 or more active pharmaceutical ingredients (APIs) in a fixed dose medicine to form a single drug
  2. There are some apprehension on the side-effects of the combined product
  3. API: It is the chemically active substance, which is meant to produce the desired effect in the body

Alternative to Small Molecule Drugs

  1. Context: BioPharmaceuticals provide an alternative to Small Molecule Drugs for Novel Treatments of previously Untreatable Diseases
  2. These drugs provide affordable options for addressing the healthcare needs of humankind
  3. R&D: Department of Biotechnology (DBT) is supporting cutting edge research for development of new Biopharmaceutical drugs in different universities, research institutes
  4. Through Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector of DBT, a number of Start-ups, SMEs and Biotech companies are developing such new drugs

Bulk drug policy to be unveiled

  1. News: Govt will come out with a new bulk drug policy in less than a month
  2. Background: India has now become a superpower in the generic drugs
  3. Objective: To grow the Indian pharmaceuticals sector to a $200 billion industry by 2030
  4. The govt wants to build an ecosystem to help pharma comapnies go up the value chain
  5. Organisation: Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers

Learn about Pharmacovigilance Programme?

  1. Context: Monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health
  2. Initiated by: The Central Drugs Standard Control Organisation (CDSCO) in 2010, under Ministry of Health & Family Welfare
  3. Coordinator: All India Institute of Medical Sciences (AIIMS), New Delhi is the National Coordinating Centre (NCC)
  4. Mission: to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use
  5. Need: To engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country
  6. Purpose: to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to health care professionals and the public
  7. Database: collects and submits suspected adverse drug reactions to a WHO database called VigiBase
  8. Indian contribution: Last year, India contributed 2% of the 2.1 million suspected reactions

India’s drug monitoring programme struggles to grow fast enough

  1. Challenges: Insufficient staff and equipment and a lack of awareness among medical professionals
  2. Unrecorded: many potentially dangerous drug reactions go unrecorded
  3. Lack of data: Gaps in the system mean the government has less data
  4. Effect: inability to determine whether drugs might have harmful side effects
  5. WHO database: Also, relatively little information flows to the WHO database of over 12 million suspected adverse drug reactions

Customs duty on life saving drugs unlikely to affect patients

Govt has imposed a customs duty of 35 % on 15 life-saving drugs but it is unlikely to affect patients

  1. This is because Indian companies are already producing these 15 drugs as generics
  2. Moreover, 6 of 15 drugs in the list (including Anti Rabies and Anti-D Immunoglobulin) already fall under the government’s price control order
  3. However, it is more viable for them to export the same drugs than sell domestically
  4. The govt tries to strengthen the taxation structure to increase domestic production
  5. Domestic bulk drug industry, which was facing a massive downturn due to Chinese imports, has got some relief

Let’s know about Haemophilia

  1. Haemophilia is a genetic disorder in which the patient tends to bleed excessively
  2. Anti-haemophilic factor concentrates (VIII & IX) are given to patients to control the bleeding
  3. These concentrates are proteins that help the blood clot
  4. Indian patients depend on American pharmaceutical company Baxter International for the proteins

Pharma and biotech sector must get its due in Budget

  1. Some of the immediate needs of the sector are access to capital, quality infrastructure, high-end talent
  2. The proposed removal of tax breaks could blunt the India pharma and biotech industry’s ‘innovation’ edge
  3. The tax exemptions given to SEZs and R&D have delivered on their stated objectives and must be further augmented to drive investment, growth and employment
  4. Today, the Indian pharma industry is recognised as the ‘Pharmacy to the World
  5. It is one of the lowest-cost producers of essential medicines globally, catering to nearly 30% of the demand for generics drugs worldwide

New U.S. rule a blow to Indian pharma exporters

  1. US govt. has made it mandatory for Active Pharmaceutical Ingredients (APIs) to be manufactured locally.
  2. At present, nearly 80% of drug raw material requirement is met by India or China.
  3. This change will affect companies which have subsidiaries in the US that procure APIs from their Indian counterparts and make the finished product in the US.
  4. Further, the decision would impact availability of affordable generics in the United States.
  5. India’s pharmaceutical Export Promotion Council has asked the govt. to intervene and resolve the issue.

Separate ministry for pharma in next one year: Ananth Kumar

  1. Union Fertilisers Minister said there would be a separate ministry for pharma and medical devices sector in the next 1 year.
  2. The govt. will soon implement the Katoch panel recommendations to cut bulk drugs import from China.
  3. India currently meets about 80% of its demand of bulk drugs, used as raw materials by the pharmaceutical industry, from Chinese imports.
  4. Govt recognises the pharma sector as a sunshine industry having a tremendous potential for growth.

Lets know about Katoch Committee recommendations

  1. The govt had set up a committee headed by V. M. Katoch, to suggest ways to reduce the dependence on bulk drug imports from China.
  2. India currently meets about 80% of its demand of bulk drugs from Chinese imports.
  3. There are recommendations like providing land at concessional rates, setting up of mega pharma parks and providing power.
  4. It also includes single window clearance for licensing of drugs in the country and setting up National Bulk Drugs Development Authority.

Bar-coding norm may hit 1,000 pharma companies

The battle for access to affordable Indian generic drugs has a new threat: bar-coding.

  1. Pharmaceutical companies in India are expected to comply with mandatory bar-coding of medicine strips, as per directives of the Commerce Ministry.
  2. From October 1, the medicine strips and containers will be expected to have a “parent-child” relationship.
  3. This means, bar-code will ensure that every unique strip of drug will go into a unique secondary package (containing the primary pack of drugs with safety instructions ).
  4. Aim is to track the origins of a shipment and to curb the distribution of spurious drugs as those manufactured in India.
  5. Nearly 1,000 small and medium-sized pharmaceutical firms, account for 40 per cent of India’s total drug exports will be out of business.

First malaria vaccine likely by October

  1. The first malaria vaccine candidate to reach phase-3 of clinical testing was found to partially protect children against the disease up to four years after vaccination.
  2. The European Medicines Agency (EMA) will assess the quality, safety, and efficacy of the vaccine.
  3. If licensed, RTS,S/AS01 (that’s the medicine name) would be the first licensed human vaccine against a parasitic disease.
  4. The RTS,S/AS01 vaccine was developed for use in sub-Saharan Africa where malaria still kills around 1300 children every day.

:( We are working on most probable questions. Do check back this section.

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