What are the components of a drug?
- Any drug is composed of two components or aspects.
- The first is the actual Active Pharmaceutical Ingredients (API), which is the central ingredient.
- The API is the chemically active substance, which is meant to produce the desired effect in the body.
- 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.
- News: According to ICRA, Indian pharma companies will face a number of challenges in the U.S. market
- Background: Indian pharma sector registered strong growth, driven mainly by the US market, on account of large brands going off patent
- Challenges: Reduced no. of big products going off patent, increased competition and rise in regulatory scrutiny
- Impact: The growth from US market has now come down from high double digits to 8-10%
Learn about Fixed dose combinations (FDC)
- FDCs are formed by combining 2 or more active pharmaceutical ingredients (APIs) in a fixed dose medicine to form a single drug
- There are some apprehension on the side-effects of the combined product
- API: It is the chemically active substance, which is meant to produce the desired effect in the body
Alternative to Small Molecule Drugs
- Context: BioPharmaceuticals provide an alternative to Small Molecule Drugs for Novel Treatments of previously Untreatable Diseases
- These drugs provide affordable options for addressing the healthcare needs of humankind
- R&D: Department of Biotechnology (DBT) is supporting cutting edge research for development of new Biopharmaceutical drugs in different universities, research institutes
- 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
- News: Govt will come out with a new bulk drug policy in less than a month
- Background: India has now become a superpower in the generic drugs
- Objective: To grow the Indian pharmaceuticals sector to a $200 billion industry by 2030
- The govt wants to build an ecosystem to help pharma comapnies go up the value chain
- Organisation: Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers
Learn about Pharmacovigilance Programme?
- Context: Monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health
- Initiated by: The Central Drugs Standard Control Organisation (CDSCO) in 2010, under Ministry of Health & Family Welfare
- Coordinator: All India Institute of Medical Sciences (AIIMS), New Delhi is the National Coordinating Centre (NCC)
- 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
- 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
- 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
- Database: collects and submits suspected adverse drug reactions to a WHO database called VigiBase
- Indian contribution: Last year, India contributed 2% of the 2.1 million suspected reactions
India’s drug monitoring programme struggles to grow fast enough
- Challenges: Insufficient staff and equipment and a lack of awareness among medical professionals
- Unrecorded: many potentially dangerous drug reactions go unrecorded
- Lack of data: Gaps in the system mean the government has less data
- Effect: inability to determine whether drugs might have harmful side effects
- 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
- This is because Indian companies are already producing these 15 drugs as generics
- Moreover, 6 of 15 drugs in the list (including Anti Rabies and Anti-D Immunoglobulin) already fall under the government’s price control order
- However, it is more viable for them to export the same drugs than sell domestically
- The govt tries to strengthen the taxation structure to increase domestic production
- Domestic bulk drug industry, which was facing a massive downturn due to Chinese imports, has got some relief
Let’s know about Haemophilia
- Haemophilia is a genetic disorder in which the patient tends to bleed excessively
- Anti-haemophilic factor concentrates (VIII & IX) are given to patients to control the bleeding
- These concentrates are proteins that help the blood clot
- Indian patients depend on American pharmaceutical company Baxter International for the proteins
Pharma and biotech sector must get its due in Budget
- Some of the immediate needs of the sector are access to capital, quality infrastructure, high-end talent
- The proposed removal of tax breaks could blunt the India pharma and biotech industry’s ‘innovation’ edge
- 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
- Today, the Indian pharma industry is recognised as the ‘Pharmacy to the World‘
- 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
- US govt. has made it mandatory for Active Pharmaceutical Ingredients (APIs) to be manufactured locally.
- At present, nearly 80% of drug raw material requirement is met by India or China.
- 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.
- Further, the decision would impact availability of affordable generics in the United States.
- 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
- Union Fertilisers Minister said there would be a separate ministry for pharma and medical devices sector in the next 1 year.
- The govt. will soon implement the Katoch panel recommendations to cut bulk drugs import from China.
- India currently meets about 80% of its demand of bulk drugs, used as raw materials by the pharmaceutical industry, from Chinese imports.
- Govt recognises the pharma sector as a sunshine industry having a tremendous potential for growth.
Lets know about Katoch Committee recommendations
- 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.
- India currently meets about 80% of its demand of bulk drugs from Chinese imports.
- There are recommendations like providing land at concessional rates, setting up of mega pharma parks and providing power.
- 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.
- Pharmaceutical companies in India are expected to comply with mandatory bar-coding of medicine strips, as per directives of the Commerce Ministry.
- From October 1, the medicine strips and containers will be expected to have a “parent-child” relationship.
- 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 ).
- Aim is to track the origins of a shipment and to curb the distribution of spurious drugs as those manufactured in India.
- 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
- 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.
- The European Medicines Agency (EMA) will assess the quality, safety, and efficacy of the vaccine.
- If licensed, RTS,S/AS01 (that’s the medicine name) would be the first licensed human vaccine against a parasitic disease.
- 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.