Essential Medicines

1. India has adopted this concept from WHO.
2. Essential medicines do not mean that they are only life saving drugs.
3. In fact, the word life saving drugs is not defined in any of the domestic legislations.
4. These are the medicines that are required to be available with the health system all the time adequately.
5. When WHO published the 1st Model List of Essential Drugs in 1977, it identified 208 individual medicines which together could provide safe, effective treatment for majority of Communicable diseases and NCDs.
6. In India, National List of Essential medicines (NLEM) specified 348 drugs which formed the basis of DPCO.

Drug Prices and Control Order (DPCO), 2013

1. DPCO are issued under Section 3 of Essential Commodities Act, 1955.
2. It gives powers to Govt to declare a ceiling price for essential and life saving medicines.
3. Price controls are applicable to "Scheduled drugs" i.e. those medicines which are listed in Schedule I of DPCO.
4. National List of Essential Medicines (NLEM), 2011 issued by MoHFW forms the basis Schedule I of DPCO.
5. Since 2013, all essential medicines (as defined under NLEM) are treated as Scheduled formulations (under DPCO 2013). It does not include any AYUSH medicine.
6. However, it does not mean that all drugs brough under price control are essential medicines.
7. Price controls are applicable irrespective of whether the drug is generic or branded.
8. National Pharma Pricing Policy (NPPP), 2012 is the policy governing price control and DPCO is the order by which price control is enforced.
9. Drug prices are monitory is monitored and controlled by National Pharma Pricing Authority (NPPA). All the powers of Govt relating to ECA are delegated to it.
   1. NPPA is an independent body of experts under Ministry of Chemicals and Fertilizers.
   2. It was formed in 1997 to implement and enforce provisions of DPCO for regulating prices of medicines.
   3. Functions:
      1. Fixing the prices of Scheduled drugs and Monitoring prices of decontrolled drugs.
      2. Monitor the availability of drugs, identify shortages, take remedial steps etc.
      3. Implement and enforce the provisions of DPCO.
10. It is important to note that Drugs and Cosmetics Act, 1940 under MoHFW do not contain provisions for pricing of drugs. Blood is a drug under Drugs and Cosmetics Act.
11. DPCOs are issued under Essential Commodities Act, 1955 by Ministry of Chemical and Fertilizers which is also the nodal agency for pharma companies. It now includes 376 medicines.
12. Under DPCO, 2013, the prices of 376 drugs have been brought under price control.
13. Generic medicine is the bioequivalent of the original drug, but cheaper.

The Central Drugs Standard Control Organisation (CDSCO)

1. CDSCO under Directorate General of Health Services, MoHFW is the National Regulatory Authority (NRA) of India.
2. Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
3. CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

India-USA Artificial Intelligence Initiative

The Indo-U.S. Science and Technology Forum (IUSSTF) has launched the U.S. India Artificial Intelligence (USIAI) Initiative.

• IUSSTF is a bilateral organization funded by the Department of Science & Technology (DST) and the U.S. Department of State.
• It will provide an opportunity for key stakeholder groups to discuss opportunities, challenges, and barriers to bilateral R&D collaboration.
• It will serve as a platform to enable AI innovation, help share ideas for developing an AI workforce, and recommend modes and mechanisms for catalyzing partnerships.

Kamakoti Committee

AI Task Force headed by V.Kamakoti was set up to explore possibilities to leverage AI for development across various fields.

Key recommendations:

• Set up digital data banks, marketplaces and exchanges to ensure the availability of cross-industry information.
• Data ombudsman: to address data-related issues and grievances.
• Ensure availability of funds for R&D
• Setting up National Artificial Intelligence Mission

Mines and Minerals (Development and Regulation) (MMDR) Amendment Bill, 2021

Lok Sabha has passed the Mines and Minerals (Development and Regulation) Amendment Bill,2021 which seeks to amend the Mines and Minerals (Development and Regulation) Act, 1957.

This act regulates the mining sector in India.

Key Provisions:

• The Act empowered the central government to reserve any mine (other than coal, lignite, and atomic minerals) for particular end-use.
  • Such mines are known as captive mines.
• The Bill removes the distinction between captive and non-captive mines.
• It provides that no mine will be reserved for a particular end-use. All mines will now be able to sell their extra minerals.
• The Bill provides that captive mines (other than atomic minerals) may sell up to 50% of their annual mineral production in the open market after meeting their own needs.
• The bill provides for the constitution of a Statutory body named the National Mineral Exploration Trust (NMET).
  • It will see the functioning of the mining sector.
• The bill proposes to introduce an index-based mechanism by developing a National Mineral Index for various statutory payments and for future auctions.
• Presently, upon the expiry of the mining lease and transfer of the lease to a new lessee, the statutory clearances issued to the previous lessee are transferred for a period of two years. The new lessee needs to obtain fresh clearances within the two years.
  • The Bill makes the transferred statutory clearances valid throughout the lease period of the new lessee.
• The bill allows the participation of private players in mining operations with enhanced technology.
• The Bill provides that if the State Government is not able to complete the auction process within a specified time, the Central Government may take over and conduct such an auction.
• The Bill says that mines (other than coal, lignite, and atomic minerals) whose lease has expired, may be allocated to a government company in certain cases.

Significance of this bill:

• The proposed reforms will raise the contribution to 2.5% as it seeks to make many mines available for auctions by resolving legacy issues.

NITI Aayog vision for Great Nicobar

• Great Nicobar Island is the southernmost island in the Andaman and Nicobar group.

• More than 150 sq. km. of land is being made available for this. This amounts to nearly 18% of the 910 sq. km. island and will cover nearly a quarter of its coastline.
• The overall plan envisages the use of about 244 sq. km. — a major portion being pristine forest and coastal systems.
• Projects to be executed in Phase I include a 22 sq. km. airport complex, a transhipment port (TSP) at South Bay at an estimated cost of 12,000 crores, and a parallel-to-the-coast mass rapid transport system and a free trade zone and warehousing complex on the southwestern coast.
• What stands out prominently in the whole process, starting with the designation in mid-2020 of the Andaman and Nicobar Islands Integrated Development Corporation (ANIIDCO) as the nodal agency, is the speed and co-ordination with which it has all unfolded.
• The other is the centrality of the NITI Aayog.
• First, on September 4, 2020, the Director, Tribal Welfare, A&N Islands, constituted an empowered committee to examine NITI Aayog’s proposals for various projects in Little Andaman and Great Nicobar Islands.
• A copy of the 2015 ‘Policy on Shompen Tribe of Great Nicobar Island’ was part of the communication sent out, giving an indication of the aims of the committee.
• Significant changes have also been effected to the legal regimes for wildlife and forest conservation.

Role of the National Board for Wildlife

• In its meeting on January 5, 2021, the Standing Committee of the National Board for Wildlife (NBWL) denotified the entire Galathea Bay Wildlife Sanctuary to allow for the port there.
• The NBWL committee seemed unaware that India’s National Marine Turtle Action Plan that was under preparation then (it was released on February 1, 2021) had listed Galathea Bay as one of the ‘Important Coastal and Marine Biodiversity Areas’ and ‘Important Marine Turtle Habitats’ in the country. It is included in Coastal Regulation Zone (CRZ)-I, the zone with maximum protection.

• Then, on January 18, another Environment Ministry expert committee approved a “zero extent” Ecologically Sensitive Zone (ESZ) for the Galathea NP to allow the use of land in the south-eastern and south-western parts of the island for the NITI Aayog plan.
• The October 2020 draft notification for this zero extent ESZ had ironically listed out in great detail the park’s ecological uniqueness — that it is part of a UNESCO World Heritage Site, houses a range of forest types, has one of the best preserved tropical rainforests in the world, is home to 648 species of flora and hosts 330 species of fauna including rare and endemic ones such as the Nicobar wild pig, Nicobar tree shrew, the Great Nicobar crested serpent eagle, Nicobar paradise flycatcher and the Nicobar megapode.
• It also notes that the park is home to the indigenous Shompen community.
• The notification says that an ESZ is needed to protect the park from an ecological, environmental and biodiversity point of view, but goes on in the very next para to propose a zero extent ESZ for nearly 70% of the periphery of the park.

Eco-Sensitive Zones (ESZ) or Areas (ESAs)

1. EPA, 1986 doesnt mention the word ESZ. Section 3 of EPA, 1986 says that Central Government can restrict areas in which industries, shall not be carried out or carried out subject to safeguards. ESZ is also identified as per Rules 5 (1) of Environment Protection Rules.
2. The purpose of ESZ was to provide more protection to parks by acting as a shock absorber or transition zone.
3. MoEF has approved the criteria to declare ESA
   1. Species Based (endemism, rarity etc.)
   2. Ecosystem-Based (sacred groves, frontier forests etc.)
   3. Geomorphological feature-based (uninhabited islands, the origin of rivers etc.)
4. It is an additional tool to strengthen buffers and corridors around the protected areas network, to check the negative impact of industrialization.
5. In this background, the National Board for Wildlife 2002 under PM adopted a "Wildlife Conservation Strategy 2002" in which 1 action was to notify lands falling within 5 km of the boundaries of National Parks and Sanctuaries as Eco fragile zones under EPA, 1986. SC in Dec 2018, has directed MoEF to declare 10 km area around NP and WS as ESZ.
6. Woodfelling, setting up sawmills, hotels or resorts; and night traffic in the zone would be restricted.
7. Forest and Wildlife Department will demarcate ESZ.