DAILY CURRENT AFFAIRS (AUGUST 30, 2022)

THE INTERNATIONAL RELATIONS

1. INDIA-BANGLADESH MOU ON KUSHIYARA RIVER

THE CONTEXT: During the 38th Ministerial Meeting of the India-Bangladesh Joint Rivers Commission, the two countries finalized a draft of a Memorandum of Understanding to share the waters of the Kushiyara River on an interim basis.
THE EXPLANATION:
• In this meeting, the two countries discussed many issues of mutual interest, including river water sharing of rivers, sharing of flood data, focus on river pollution, joint study on sedimentation management, river bank protection between the two countries. tasks etc.
• All aspects of issues related to Ganga, Teesta, Manu, Muhuri, Khowai, Gumti, Dharla, Dudhkumar etc. other rivers were also discussed during this meeting.
• Meanwhile, both sides welcomed the finalization of the design of Feni River Water Harvesting Site and its technical infrastructure to meet the drinking water requirements of Sabroom Town, Tripura. It is noteworthy that in this regard, an MoU came into existence between the two countries in October 2019.
VALUE ADDITION:
Kushiyara River
The Kushiyara River forms the Indo-Bangladesh border as a branch of the Barak River when it separates from the Surma, another branch of the Barak. After flowing some distance in Bangladesh, it meets again with Surma river and this combined river is now called Meghna river.
Manipur, Mizoram and Assam receive water through this river in India.
India and Bangladesh water sharing
• India and Bangladesh share 54 between them. All the rivers of Bangladesh either have their source in India or pass through it.
• The Ganges, the major river system in India, flows through Bangladesh into the Bay of Bengal. About 35 million people in about one third of Bangladesh’s area are directly dependent on the Ganges.
Joint River Commission
• The Joint River Commission between India and Bangladesh was formed in the year 1972 under the peace treaty, through which issues of mutual interest on the border, border rivers can be resolved.
• The JRC is headed by the Ministers of Water Resources of both the countries.
• Under this commission, meetings are organized to get mutual benefit from the rivers located between the two countries and to discuss river related issues from time to time.

THE HEALTH ISSUES

2. 75 TRIBAL DISTRICTS IDENTIFIED FOR TB INTERVENTIONS

THE CONTEXT: Recently 75 high burden tribal districts have been selected by the Ministry of Tribal Affairs and the Central TB Division of the Ministry of Health and Family Welfare to become TB free in the coming months.
THE EXPLANATION:
For 75 such districts, a three-pronged strategy is presented, focusing on the following:
1. Generate demand for TB services through community mobilization, increasing awareness of TB symptoms, prevalence and treatment procedures, and continuing engagement with community influencers involved in the process of reducing stigma and fear associated with TB.
2. To improve the delivery of TB services by provision of customized solutions by leveraging PIPs and other sources of funding to bridge the implementation gap by increasing the infrastructure of TB testing or testing and diagnosis.
3. Reducing the risk and spread of disease through proactive case-detection campaigns.
Tribal TB Initiative
• The ‘Tribal TB Initiative’ is a joint initiative of the Ministry of Tribal Affairs and the Central TB Division of the Ministry of Health, supported by USAID as the technical partner and by Piramal Health as the implementation partner.
• Under this initiative, Aashwasan Campaign was launched from Nandurbar district of Maharashtra to detect active cases of TB in 174 tribal districts of India.
Aashwasan Campaign
• The campaign has brought together around 2 lakh community influencers, who participated with full dedication to make this campaign a success. These include tribal leaders, tribal doctors, PRI members, self-help groups (SHGs) and youth from tribal areas.
• Under this, door-to-door TB screening was done in 68,019 villages. Based on oral examination of 1,03,07,200 persons, 3,82,811 persons were identified as having TB.
• Of these, 2,79,329 (73 per cent) samples were tested for TB and 9,971 people tested positive for TB were treated as per the protocol of the Government of India.
End TB strategy
India is committed to eliminate tuberculosis from the country by 2025, five years ahead of the World Health Organization’s (WHO) global target i.e. 2030.

THE GOVERNMENT SCHEMES AND INITIATIVES IN NEWS

3. 8 YEARS OF PM JAN DHAN YOJANA

THE CONTEXT: Recently, the central government’s ambitious scheme Pradhan Mantri Jan Dhan Yojana has completed eight years. The main objective of this scheme was to include the poor section of the country in the main banking system.
THE EXPLANATION:
Under this scheme more than 46 crore bank accounts have been opened in 8 years. It has deposits of Rs 1.74 lakh crore. With the help of this scheme, 67 percent of the rural population of the country has now got banking services and 56 percent of women also have Jan Dhan accounts.
Key Features of the Scheme
The schemes would provide the connectivity to the individuals through banking facilities. Several key features of the scheme include:
• Interest on deposit
• Accidental insurance cover of Rupee One Lakh.
• No minimum balance required
• Life insurance cover of Rs.30,000/-
• Easy Transfer of money across India
Further, the beneficiaries of Government Schemes would get Direct Benefit Transfer in these accounts; After satisfactory operation of the account for 6 months, an overdraft facility will be permitted; Access to Pension, insurance products.; Accidental Insurance Cover, RuPay Debit Card must be used at least once in 45 days; Overdraft facility uptoRs.5000/- is available in only one account per household, preferably lady of the household.
With the help of this scheme, the financial help sent by the central government to the poor during the covid-19 pandemic was directly transferred to their bank accounts. This made it possible for the financial assistance given under other schemes including Pradhan Mantri Kisan Samman Nidhi to reach the beneficiaries directly.
Challenges to Jan Dhan Scheme
• Usage of bank accounts is limited.
• Banking infrastructure has not reached rural areas, thus declining usage.
• Financial literacy is low.
• Availability of loans and credit for rural areas is less.
• A significant population is still without any bank accounts.
PMJDY is a significant scheme to ensure inclusive development and channelize savings in the economy. The focus should now shift to increasing bank reach in rural areas and including all unbanked population in a scheme rather than focusing on one member per family.

THE PRELIMS PERSPECTIVE

4. ALL MANIPUR SHUMANG LEELA FESTIVAL 2021-2022

THE CONTEXT: Recently, the 50th All Manipur Shumang Leela Festival 2021-2022 began at Iboyaima Shumang Leela Shanglen in Palace Compound, Imphal.
THE EXPLANATION:
• Shumang Leela is a traditional form of theatre in Manipur and the roles of female artists are all played by male actors and male characters are played by female artists in case of female theatre groups. The activities are done in the open air.
• During the festival, the Governor also distributed medals to the winners of the 49th All Manipur Shumang Leela Mahotsav 2020-21.
Background of Shumang Leela Festival
• Originally Shumang Leela began as a comedy genre presented to kings and nobles, which evolved into the present form of courtyard drama. The Shumang Leela of those days tried to preserve and promote humanity, tolerance, self-confidence, devotion, truth and justice through its performances.
• In the present day Shumang Leela is trying to focus on issues of moral values, unity and integrity. It is also striving to strengthen the bonds of brotherhood and friendship between different communities in the state.

5. AUGUST 29: NATIONAL SPORTS DAY

THE CONTEXT: The National Sports Day (NSD) is celebrated every year in India on 29th of August to mark the birth anniversary of legendary hockey player Major Dhyan Chand, who was known as ‘The Wizard’ or ‘The Magician’ of hockey for his superb ball control.
THE EXPLANATION:
About Major Dhyan Chand
• The legendary hockey player was born on 29 August 1905 in Allahabad, Uttar Pradesh. He is widely considered as the greatest field hockey player of all time. He had started playing hockey only after joining the Army at the age of 16.
• He won gold medals in Olympics for India in the years 1928, 1934 and 1936. He scored over 400 goals in his career, from 1926 to 1948. It is believed that after India defeated Germany in the 1936 Olympics final by 8-1, Adolf Hitler offered him a senior post in the German Army, to which Chand refused.
• His autobiography “Goal!” was published by Sport & Pastime (Madras) in 1952. The Government of India (GoI) awarded him the 3rd highest civilian honour of Padma Bhushan in 1956. Beside this, the most noted memorial for him is the Major Dhyan Chand Award, which is the highest award for lifetime achievement in sports and games in India.
• It has been awarded annually from 2002 to sporting figures that not only contribute through their performance but also contribute to the sport after their retirement.

6. SAREX 22 INDIAN COAST GUARD EXERCISE

THE CONTEXT: The Indian Coast Guard recently conducted its biennial National Maritime Search and Rescue Exercise SAREX 22 off the Chennai coast.
THE EXPLANATION:
• The objective of this exercise is to avoid accidents at sea and save lives by conducting rescue operations. During this, 24 observers from 16 countries participated in the exercise organized under the theme ‘Capacity Building Towards Maritime Security’.
• This was the 10th exercise conducted by the Coast Guard. During this exercise, new technology like remote controlled lifebuoys were demonstrated over the Bay of Bengal.
Indian Coast Guard
It is an armed force, search and rescue agency that protects maritime interests of India. It is a Maritime Law Enforcement Agency. It was established in 1978 by coast Guard Act, 1978. It operates under Ministry of Defence.
The following are the missions of Indian Coast Guard-
1. To protect artificial Islands
2. To protect marine ecology and environment
3. To protect fishermen and mariners at ea
The responsibilities of the Indian Coast Guard are Offshore security coordination, national maritime search and rescue, coastal security.

7. VAJRA PRAHAR: INDIA-US JOINT MILITARY EXERCISE, 2022

THE CONTEXT: The 13th edition of India-US Joint Special Forces Exercise Vajra Prahar recently concluded in Bakloh, Himachal Pradesh. Earlier, its 12th edition was held in October 2021 at Joint Base Lewis Mc Cord in Washington, USA.
THE EXPLANATION:
• During this 21-day joint training, the special forces of both the countries underwent training in special operations, air operations and counter-terrorism operations in a joint environment under the United Nations Charter.
• The exercise was conducted in two phases. The first phase includes combat adaptation and tactical level special mission training exercises. At the same time, under the second phase, 48 hours of verification of training received by both the parties has been included in the first phase.
Vajra Prahar
• ‘Vajra Prahar’ is an Indo-US Special Forces joint training exercise that began alternately in 2010 in India and the US.
• The aim of the exercise is to boost military ties between the two countries by enhancing reciprocity and mutual exchange of strategies between the Special Forces.
• This joint training helps in developing a joint strategy between the two armies by sharing best practices and rich pool of experiences of each other’s armies as well as expertise in operations in counter-terrorism and counter-terrorism environments.




Day-276 | Daily MCQs | UPSC Prelims | GEOGRAPHY

[WpProQuiz 320]




TOPIC : REGULATORY ISSUES IN THE INDIAN DRUG AND PHARMACEUTICAL SECTOR

THE CONTEXT: Recently, the Central Bureau of Investigation (CBI) has arrested a top official of the Central Drugs Standard Control Organisation (CDSCO), the regulatory body for drug approvals in India, and a senior official in charge of regulatory affairs of a Bengaluru-based pharmaceutical firm as well as officials of a company acting as middlemen on behalf of the pharma company. This development again raised questions on the flaws in the drug regulation in India and highlighted the need for a strong mechanism for drug and pharmaceutical regulations. Daily analysis for the issue is as follows.

THE SIGNIFICANCE OF REGULATION

The regulatory scenario in this sector is extremely crucial not only due to the rapid and ongoing changes at the global level, largely with reference to good manufacturing practices (GMP), good clinical practices (GCP)and good laboratory practices (GLP) but also due to the onus on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the Indian masses.

WHY THERE IS A NEED FOR REGULATION?

REASON

DETAILS

INFLATED FEES BY PRIVATE HOSPITALS

  • The Drug Price Control Order of 2013 stipulates a ceiling of MRP for medicines mainly in the national list of essential medicines and has provided full freedom to the pharmaceutical companies to fix the MRP at a high level.
  • This provides the regulatory space to facilitate corporate hospitals to demand high mark-ups from pharmaceutical companies.
  • The NPPA analyses show that a major portion of hospital bills – 55% – is payments for medicines and other consumables.

Case study:

  • In 2017, the country was shocked to hear that two families had to pay nearly Rs 16 lakhs each for the two weeks of inpatient care of their children for the treatment of dengue-related complications.
  • The National Pharmaceutical Pricing Authority (NPPA) inquiry into these two inflated charges revealed that hospitals were producing medicines at a cheap price and selling them to patients at the maximum retail price (MRP).
  • An analysis, by the National Pharmaceutical Pricing Authority (NPPA), of Fortis Hospital’s bill of medicines and consumables of one such patient, shows the exorbitant charges: an IV Infusion set procured for Rs. 8.39 is sold to the patient for Rs. 115, a margin of 1,271 per cent. Similarly, a disposable syringe procured for Rs. 15.90 was sold to the patient for Rs. 205, a margin of 1,189 per cent.
  • The analyses of the hospital bills found a mark up between 375% and 1700%.

FAILED PAST ATTEMPTS DUE TO REGULATORY LOOPHOLE

  • Past experiences show that even if the government caps the margins or prices of the consumables, the hospitals then increase the charges for procedures and other services and refuse to pass on the benefit to the patients.
  • Example: In the case of cardiovascular stents, immediately after the prices were capped, hospitals increased the charges for procedures.
  • Therefore any effective remedy to ensure affordable healthcare charges can be done only through the ceiling of healthcare charges in private hospitals.

SHRUGGING OFF THE RESPONSIBILITY BY THE CENTRAL GOVERNMENT

  • With health being a State subject, the Central government says it cannot step in to regulate healthcare charges.
  • The Central Clinical Establishment Rules, which is to implement the Central Clinical Establishment Act (CEA) stipulates that the clinical establishments shall charge the rates for procedures and services fixed by the Central government in consultation with the state government.
  • Though the rules were framed in 2012, the Central government has not fixed the rates.
  • Draft Charter of Patients Rights, a joint initiative of the National Human Rights Commission and Ministers of Health is also silent on the ceiling of health charges.
  • The Charter, without any regulation or ceiling on healthcare charges, would not offer any relief to the people who are exposed to financial exploitation from private sector hospitals.

INTERNATIONAL AND CONSTITUTIONAL OBLIGATIONS

  • India, as a party to the International Covenant on Social and Economic Cultural Rights, has an international obligation to protect its population from the exploitation of private hospitals.
  • Similarly, the right to health is recognised as a fundamental right under Article 21 of the constitution which places a constitutional obligation upon both the Union and state governments to regulate healthcare charges.

NO CLEAR DEFINITION/REGULATION FOR GENERIC AND SPURIOUS DRUG

  • There is no definition of generic or branded medicines under the Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder.
  • However, Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 prescribes that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drug.
  • But, the regulation related to both medicine is not implemented so far. There is a clear vacuum related to their in terms of regulation and difference of both these drug.

PROMOTION OF DOLO DURING RECENT PANDEMIC

  • In the absence of clear guidelines and regulation, DOLO  non-steroidal anti-inflammatory drugs (a harmful pain killer) promoted at wide level.
  • This shows that why there is need for an effective regulations for such of harmful medicine.

MAJOR BODIES REGULATING DRUGS AND PHARMACEUTICALS

MINISTRY OF HEALTH AND FAMILY WELFARE

Directorate General of Health Services (DGHS) Indian Council of Medical Research (ICMR)

Central Drugs Standard Control Organization (CDSCO) headed by the Drug Controller General of India, DCGI (I) + Statutory Committees + Advisory Committees +

State Licensing Authorities

MINISTRY OF CHEMICALS AND FERTILIZERS

Department of Pharmaceuticals

National Pharmaceutical Pricing Authority (NPPA): Drugs (Prices Control) Order (DPCO) 2013

MINISTRY OF COMMERCE

Patent Office

Controller General of Patent

MINISTRY OF SCIENCE AND TECHNOLOGY

Department of Biotechnology (DBT)

Council of Scientific and Industrial Research (CSIR) Laboratories

MINISTRY OF ENVIRONMENT

Environmental clearance for manufacturing

ROLE OF DIFFERENT DRUG REGULATING AGENCIES

The Central Drug Standards and Control Organization (CDSCO)

(Ministry of Health and Family Welfare)

  Prescribes standards and measures for ensuring the safety,

  Efficacy and quality of drugs, cosmetics, diagnostics and devices in the country;

  Regulates the market authorization of new drugs and clinical trials standards;

  Supervises drug imports and approves licences to manufacture the above-mentioned products.

The National Pharmaceutical Pricing Authority (NPPA),

( Department of Chemicals and Petrochemicals)

  Fixes or revises the prices of decontrolled bulk drugs and formulations at judicious intervals;

 Periodically updates the list under price control through inclusion and exclusion of drugs in accordance with established guidelines;

  Maintains data on production, exports and imports and market share of pharmaceutical firms;

 Enforces and monitors the availability of medicines in addition to imparting inputs to parliament on issues pertaining to drug pricing.

STATE DRUG REGULATING AUTHORITY(SDRA)

  Licenses and monitoring manufacture,

  Distribution and sale of drugs and other related products.

THE LEGAL FRAMEWORK FOR PHARMA SECTOR

In India, drug manufacturing, quality and marketing are regulated in accordance with

  1. Drugs and Cosmetics Act of 1940 and Rules 1945
  2. Pharmacy Act of 1948
  3. Drugs and Magic Remedies Act of 1954
  4. Drug Prices Control Order (DPCO) 1995, 2013

In accordance with the Act of 1940, there exists a system of dual regulatory control or control at both Central and State government levels

INSTITUTIONAL ISSUES RELATED TO REGULATING BODIES IN PHARMA SECTOR

(ADMINISTRATION)

REGULATING BODIES

ISSUES                 

THE NATIONAL PHARMACEUTICAL PRICING AUTHORITY

  • NPPA chairman is an officer of the secretary level from   Indian administrative services.
  • There is no fixed tenure of chairmen. Further, there are no permanent staff at NPPA.
  • For implementing its order, NPPA has to depend upon state authorities.
  • NPPA can only control the price of drugs which are under NLEM (which is in stark contrast with its motto “affordable medicine for all”) previously, it can control prices of other drugs also using Para 19 of DPCO order, but it has since been deleted.

THE CENTRAL DRUG STANDARDS AND CONTROL ORGANIZATION (CDSCO)

Lack of access to resources (both physical infrastructure and human resources)

THE DRUGS CONTROLLER GENERAL OF INDIA (DCGI)

MDs in pharmacology and/or microbiology are given preference for appointment to the job of the Drugs Controller General of India (DCGI): this can generate a conflict of interest sometimes.

STATE DRUG REGULATORY AUTHORITY(SDRA)

  • Most of the regulators are pharmacists: this creates a conflict as; most of the regulators at the central level are Doctors.
  • Lack of access to resources (both physical infrastructure and human resources)

From the table below it will be clear that both the CDSCO and the SDRAs exercise regulatory control exclusively on the basis of executive fiat and delegation. In effect, both have limited Pre Manufacturing Distribution and Sale Post Marketing operational freedom and, therefore flexibility, to develop and operationalise their regulatory powers.

CHALLENGES IN PHARMA REGULATION SECTOR (FUNCTIONING)

AUTONOMY

  • Both the CDSCO and the SDRAs are umbilically tied to their parent ministries and departments of health respectively. This impedes flexibility in decision-making and autonomy in a host of areas beginning with finance, recruitment and other areas of institutional policy. Regulators are effectively accountable to bureaucrats in their respective parent ministries.
  • Any decision passes through various ministerial channels,weakening the autonomy of CDSCO.
  • The CDSCO is not a statutory body and, therefore, is not independent of the MOHFW. The CDSCO is headed by the Drugs Controller General of India (DCGI). A similar structure operates at the state level where the State Drug Controller (SDC) heads the SDRA and reports to a joint secretary in the health department of state government AND HENCE OVERLAPPING JURISDICTIONS.
  • Fees collected by the CDSCO are routed through the Department of Health, thus budgetary allocation is the only source of finance
  • Fragmented drug regulators further decrease their autonomy as the power to regulate the Drug industry is at different levels VIZ. CDSCO,NPAA,SDRA
  • Lack of hierarchy between CDSCO and the SDRAs as both are legally entitled to function autonomously since ‘health’ is a subject; this creates a continuous challenge in ensuring harmonised application of drug regulatory standards throughout the country.

POWER

  • Section 33P15 which empowers the CDSCO to issue directions to SDRAs, to ensure that provisions of DCA are implemented uniformly in all states, has been rarely used and, even if it is used, the CDSCO has no power to enforce compliance by states.
  • Drug inspectors have no assurance of their safety and do not have the power to arrest
  • power of  SDRA to inspect the drug  only at the market level (off the sleeve whereas in most of the countries it is done at the process level)
  • lack of power to punish the doctors who give verbatim  because of pharmaceutical lobbying   on clinical trials of drugs

CAPACITY

  • AT THE ADMINISTRATIVE LEVEL, Lack of access to resources (both physical infrastructure and human resources.
  • AT THE FINANCIAL LEVEL, BOTH ORGANISATION COMPLETELY  DEPENDS UPON BUDGETARY ALLOCATION, and a minimal user fee is charged  FROM THE INDUSTRY
  • lack of planning and execution of training programmes for drug inspectors/ad hoc in approach
  • institutional channels of interaction between the CDSCO and the SDRAs are lacking.

1. Method to calculate ceiling prices

  • DPCO, 2013 lays down a complicated formula: “(Sum of prices to the retailer of all the brands and generic versions of the medicine having market share more than or equal to one per cent of the total market turnover on the basis of moving annual turnover of that medicine) / (Total number of such brands and generic versions of the medicine having market share more than or equal to one per cent of total market turnover on the basis of moving annual turnover for that medicine.)”
  • In other words, the ceiling price is the average of price of all brands of medicine with more than 1% market share.

WHAT ARE THE SHORTCOMINGS IN THE PRESENT SYSTEM OF CONTROL IN INDIA?

HEALTH INSURANCE SCHEMES ARE NOT EFFECTIVE

  • Instead of directly intervening and regulating the healthcare charges, the state and Central governments intervened through insurance schemes to reduce the financial burden of patients.
  • These schemes function as a cross-subsidization or by increasing footfalls for the private sector.
  • Studies have shown that even after insurance schemes like the Rashtriya Swasthya Bima Yojana (RSBY) and various state government-sponsored insurance schemes; there is no change in the burden of out-of-pocket expenditure.
  • Often hospitals use these schemes to attract patients and charge them heavily by offering services outside the scheme.

REGULATORY CAPTURE

  • Regulatory capture is a phenomenon when a regulatory body gets influenced by the economic interests of special interest groups that dominate the industry, rather than those of the general public.
  • A regulatory capture is a form of government failure, where government agencies fail to perform their duties.

WEAK IMPLEMENTATION BY THE GOVERNMENT

  • Loopholes in policy design are complicated by weaknesses in implementation.
  • The government leaking out information on the dosage of a drug whose price is under regulation is an example of a loophole in policy design.
  • Also,

NO DETERRENCE OF PUNITIVE ACTIONS

  • There are no punishment methods if a firm fails to adhere to the price cap or is strategically launching a new variant of the drug to bypass regulation.
  • Violation of the price-cap ceiling imposed by DPCO 2013 has not attracted any punitive consequences for firms.

NO EFFECTIVE MONITORING MECHANISM

  • Neither the Department of Pharmaceuticals nor the National Pharmaceutical Pricing Authority has the institutional ability to monitor the prices of medicines at the state level. Such capacities are key to the enforcement of the regulation.

OVERVIEW OF MAJOR REFORM EFFORTS

ON AUTONOMY

RANJIT ROY CHAUDHARY COMMITTEE REPORT

CDSCO should be upgraded to a separate organisation with functional and financial autonomy. DCGI qualification and experience should be similar to that of a secretary or director general.

MASHELKAR COMMITTEE REPORT

Independent CENTRAL DRUG AUTHORITY  reporting directly to the Ministry of Health.

Financing

59th Report on the Functioning of CDSCO

MOHFW should work out a fully centrally sponsored scheme for the purpose so that the state drug regulatory authorities do not continue to suffer from a lack of infrastructure and manpower anymore.

Mashelkar Committee Report

Requires more budgetary allocation for setting up world-class drug controlling authority

MANPOWER

Ranjit Roy Chaudhary Committee

Identification and creation of positions in different disciplines have become more important in drug regulation. this can be solved by better emoluments

Mashelkar Committee

creation of new posts

 Augment no. of drug inspectors

 The capabilities and skills of enforcement staff need to be upgraded

59th Report on the Functioning of CDSCO

Engagement of medically and professionally qualified persons on a short-term contract or on deputation basis of interest agreements.

Infrastructure

Ranjit Roy Chaudhary Committee

Expand the current pharmacovigilance programme to cover the whole country by strengthening Zonal and sub zonal office

Mashelkar Committee

The state must provide adequate infrastructure for the office of DRA, including vehicles and the purchase of samples.

59th Report on the Functioning of CDSCO

Upgrade existing offices and set up new offices

Strengthen both central and state drug testing laboratories

THE WAY FORWARD:

QUALITY + AFFORDABILITY

Ø  The system of healthcare in India should be balanced between quality healthcare and affordability.

Ø  To achieve this, both policymakers and firms need to meet somewhere mid-way to find a win-win solution.

ROLE OF CENTRAL GOVERNMENT

Ø  The Central government, which has the experience of capping the price of healthcare services under the CGHS scheme, should use its powers under the Concurrent List to stop the burden-shifting and establish a regulatory authority to fix ceiling prices on healthcare services.

Ø  Even though health is listed as a state subject, the constitution provides the Union government with enough powers to regulate healthcare fees.

Ø  Article 243 of the constitution provides legislative competence to the Union government to legislate upon any subject matter in the state list to fulfil an international obligation.

Ø  The concurrent list entries, like price control and essential services, provide powers to the Central government to regulate the healthcare charges of private hospitals.

REFORMS IN THE DRUG DISTRIBUTION SYSTEM

Ø  The drug distribution system could be reformed in India, by building up the scale and scope of generic medicine pharmacies as in the Jan Aushadhi Programme, a campaign launched by the Government of India to provide quality generic medicines at affordable prices to the masses.

SUPPLY-SIDE REFORMS

Ø  The industry’s reputation from the supply side can be improved by responsible pricing behaviour and complementary programs to enhance the diffusion of their medicines and healthcare products to the less privileged at highly subsidised prices.

THE CONCLUSION: At the helm, we need persons of vision with an understanding of the importance of evidence-based medicine in public health and curative healthcare, as well as an understanding of the general progress of the science of medicine, pharmacology and pharmaceutics – these may be found in a wide range of associated disciplines, for mitigating the case of conflict of interest. National pharmaceutical policy is an opportunity to radically clean the anarchy in drug regulation in India in the interests of public health. Surely, “The Pharmacy of the World” deserves a better regulatory body.

MAINS QUESTIONS

  1. Discuss the regulatory loopholes in the healthcare system in India, especially related to drug price control.
  2. With healthcare being a State subject, the Centre has less power and responsibility in ensuring the right to health for everyone. Do you agree with the statement? Give reasons to justify your viewpoint.
  3. Discuss the strategies that can be applied to make healthcare in India affordable to each and every one.