Champion Sectors in Services

Department of Commerce, Ministry of Commerce and Industry to give focused attention to 12 identified Champion Services Sectors for promoting their development, and realizing their potential

Information Technology & Information Technology enabled Services (IT & ITeS),
Tourism and Hospitality Services,
Medical Value Travel,

Transport and Logistics Services,

Accounting and Finance Services,

Audio Visual Services,
Legal Services,

Communication Services,
Construction and Related Engineering Services,
Environmental Services,
Financial Services and

Education Services.

NITI Aayog is not related to Champion Sectors

Also refer Champions Sectors in Manufacturing

Software Technology Park of India STPI

Autonomous society under the MeitY
Aim is to make India a global IT super power
Its objective is to promote the development and export of software and software services including IT enabled services and provide statutory and other promotional services to the exporter by implementing Software Technology Park and other schemes

Health/Pharma sector

Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945.

In India, Blood is considered to be a ‘dru under the Drugs & Cosmetics Act, 1940 and in 2020, Medical Devices also been considered as Drugs under Drugs and Cosmetic Act 1940

Nutraceuticals

Nutraceuticals are supplements and foods that aren’t drugs but purported to conta ingredients essential to well-being such as obesity pills, diet regimens shakes with exaggerated benefits etc
A centre was set up under National Institution of Nutrition, Hyderabad to regulate nutraceutical industry according to the guidelines by FSSAI last year

Digital therapeutics / Digiceuticals

It is 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

Biopharmaceutical

Also known as a biological medical product
It is any pharmaceutical drug product manufactured in, extracted from, or semi synthesized from biological sources.

Ready-to-use Therapeutic Food (RUTF) / Energy dense nutritious food (EDNF)

RUTF includes readymade packed paste made of high energy fortified supplements (peanuts, oils, dried milk etc.) being administered to the child under doctor supervision to cure Severe Acute Malnutrition (SAM) among children
The paste is administered to children aged between 6 months and 6 years daily for about a month.
It is cost-effective and hygienic as it has low human contact as compared to freshly cooked food.
It is being implemented under the global initiative Scaling Up Nutrition movement and ICDS in India, through collaboration with the state governments.

Recently, GOI notified to stop this as this concept is has flaws

Secondary Patents

Patents offer the market exclusivity to their owners for a limited period of time
For medicine, this market exclusivity lasts upto 20 years from the primary patent granted stage.
After this period, drug prices fall steeply afterwards — by as much as 80% — owing to eric competition
However, Pharmaceutical companies to counter this, find new ways to postpone their exclusivity by filing secondary patents for derivatives and variants of the API (Active Pharmaceutical Ingredient), such as a physical variant of the API, a new formulation, a dosage regimen, or a new method of administering the medicine.
The secondary patents prop up before the expiry of a primary patent thereby stretching the exclusivity beyond, a practice that is called “evergreening”

Data Exclusivity

Data exclusivity prevents drug regulators from referring to or relying on data submitted by an originator company relating to a drug’s safety and efficacy while approving bioequivalent versions of the same drug
If the data exclusivity granted to companies, the clinical trials /data generated during the drug development will not be shared to anyone
So, the problem is that the other companies/generic drug companies has to repeat all the clinical trials again for developing the equivalent drug
This hampers and delays the development of generic drugs which in large against public interest
Generic drugs are cheaper
In India, there is no provision of granting Data exclusivity to drug companies unlike west
Companies are lobbying to get the license of data exclusivity

Capping on price of stents

National Pharmaceutical Pricing Authority (NPPA) [not statutory body]- cap on price of stents used to treat coronary artery disease
Overall dominance of private, commercial, for profit health institutions, and the asymmetry confronting citizens, unethical and irrational use of medicines
Pros:

Accessible health care to poor
Irrational use of medical technologies, including cardiac stents and knee implants

Using them even when they are not required

US firms have approached the United States Trade Representative (USTR) against the price capping of stents by India Govt. with a request to either suspend or withdraw India’s benefits under Generalized System of Preferences (GSP).

Central Drugs Standard Control Organization CDSCO

Ministry of Health and Family Welfare
National regulatory body for Indian pharmaceuticals and medical devices (both notified and non-notified)
Functions

Regulatory control over the import of drugs, approval of new drugs and clinical trials,
Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB),
Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

Under the Drug and Cosmetics Act 2005

Regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities.
Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Drug Controller General of India (DCGI)

Head of the Central Drugs Standard Control Organisation

Drug Controller General of India (CDSCO) along with State regulators is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera

National Pharmaceutical Pricing Authority (NPPA)

Non statutory , independent body
Ministry of Chemical and Fertilizers

Note: Drug standard organisation is under Ministry of Health and Family welfare while pharmaceutical pricing under ministry of chemical and fertilizers

To fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995 & Drugs (Prices Control) Order, 2013
Monitors prices of decontrolled drugs in order to keep them at reasonable levels.
only the prices of drugs that figure in the National List of Essential Medicines (NLEM) are monitored and controlled by National Pharmaceutical Pricing Authority.

National List of Essential Medicines (NLEM)

Criteria for inclusion: Includes public health emergency, cost effective medicine etc.
Core Committee formed by the Ministry of Health, reviews and revises the medicines in the NLEM

NOTE: Not by NPPA/ICMR/CDSCO

Once a drug or medical device is included in NLEM, its price can be capped by NPPA

National Essential Diagnostics List NEDL

Compiled by Indian Council of Medical Research ICMR

Drugs Management

CDSCO/DCGI

Approval of new drugs

Quality check of import drugs

Clinical trails

Standards

NPPA

Pricing of Drugs that are in National List of Essential Medicines

State DCO

Manufacture, Sale, Distribution of Drugs

DCGI & State DCO

blood and b lood products, I. V. Fluids, Vaccine and Sera

Service Sector