Process improvement for government drug procurement in India

 In India, drug quality is an important problem. Government agencies are an important buyer of drugs, and also face significant problems with drug quality. In this paper, we examine the mechanisms used for drug purchase by four Indian states - Rajasthan, Punjab, Bihar and Gujarat. We establish a taxonomy of 13 design elements that define the drug procurement process. We engage in deductive reasoning about the design elements that appear to be useful and those that are less so. This work would help policy makers placed in an Indian public sector context in devising better procedures for drug purchase.

Citation: Process improvement for government drug procurement in India, Harleen Kaur, Ajay Shah, and Siddhartha Srivastava, XKDR Working paper 18, December 2022

Read more here: https://www.xkdr.org/paper/process-improvement-for-government-drug-procurement-in-india

Response To Trai Consultation Paper On Issues Related To New Regulatory Framework For Broadcasting And Cable Services

TRAI published a Consultation Paper on Issues related to new Regulatory Framework for Broadcasting and Cable Services on May 7, 2022 (https://www.trai.gov.in/consultation-paper-issues-related-new-regulatory-framework-broadcasting-and-cable-services)

In our response, we argue that TRAIs policy of fixing tariffs of television channels (by regulating the pricing of bouquets or discounts that can be provided thereon, etc.) is an arbitrary and disproportionate intervention. Not only has TRAI failed to demonstrate evidence of harm to implement such an intrusive regulatory tool, the intervention has also failed to have any significant social or economic benefit. Accordingly, we suggest that TRAI revise its tariff policy and engage in regulatory forbearance. Alternatively, deregulation could be considered in specific markets/geographies, to provide an appropriate evidence base to gauge the results of competition and therefore fine-tune the regulatory system.

Link to the response

Citation: Response to TRAI Consultation Paper on Issues related to new Regulatory Framework for Broadcasting and Cable Services, Rishab Bailey, Devendra Damle, Harleen Kaur, Ajay Shah, May 2022 

Comments on the National Dental Commission Bill, 2020

Summary of recommendations

This response presents my comments on the Draft National Dental Commission Bill, 2020 (“ NDC Bill”) proposed by the Ministry of Health and Family Welfare. The Bill offers a fairly comprehensive set of provisions for regulating the profession and education relating to Dentistry. However, for the reasons explained in more detail in the response below, the position adopted by the Bill on certain key issues needs to be revisited. These are summarised in the present section:

1. The present bill drops the requirement to regulate the profession and education of Dental Hygienists (DHs) and Dental mechanists (DMs) from under the domain of the regulator. It is an established fact that the profession of dentistry requires contribution from the DHs and DMs. Therefore, it is recommended that the NDC Bill includes provisions for the regulation of DHs and DMs. This may be specified in the functions of the NDC and its Autonomous Boards. Due representation of DHs and DMs may be provided in these Boards.
2. The preamble of the NDC bill should iterate “patient safety” as the objective of the NDC. Patient safety is seen universally as the ultimate goal of a regulator in the field of health services and a clear ultimate objective of patient safety would enable the NDC to align its regulations for this goal.
3. The definition of the terms dentists and dentistry need to be modified. This is required to include promotive healthcare as a function of dentists, including only qualified personnel as dentists as well as including promotive functions and ‘oral health’ as a function of dentistry. The detailed suggestions, as well as the rationale, is provided in the comments below.
4. The definition clause should also include definitions for terms like ‘Oral Health’, ‘Dental Hygienists’ and ‘Dental Mechanics’.
5. The term of the “part-time” members of the NDC board and Autonomous Boards may be increased to be at par with the term of the Chairperson to allow for an uninterrupted functioning of the Board. The Board should be prescribed to record the proceedings of the meetings held by it and the provision for cases where decision-making occurs without conducting the meetings should be well specified in the NDC Bill.
6. It is recommended that clause 9(6) giving appellate power to the central government over decisions of the Board should be removed to reduce the risk of conflict of interest and preserve the autonomy of the NDC.
7. The following best principles of regulation be added to the NDC Bill: 
• The NDC Bill should ensure that the regulation-making process be overseen by the Board to increase accountability of the Board.
• Process of public participation in regulation-making should be standardised and put in the NDC Bill.
• The NDC Bill should provide for strong executive powers, balanced with greater transparency and accountability, to prevent abuse. For instance, the inspection planning guidelines, inspection reports, and action taken reports should be publicly available.
• Judicial & quasi-judicial functions to be performed by the NDC should follow the proportionality principle. For instance, the NDC could develop a graded system of inspection results for dental schools and its effects on a scale from needs no improvement to recommend derecognition. Derecognition should be recommended in extreme cases and should include a transition plan for students.
8. It is recommended that the NDC Bill specify limited or fixed-terms of appointment, extendable to a second term for the members of the Dental Advisory Council. It is also recommended that the functions of the Council mandate creating a report on all draft regulations published by the regulator stating the council’s views under clause 12.
9. As elections are time-consuming and expensive, as well as the rationale for having part-time members is unclear, it is recommended that the term of all members of Autonomous Boards be made four years to enable the Boards to function without interruptions. 
10. Given that a need has been felt for ensuring regular inspection of existing dental colleges in the past, it is recommended that ongoing quality assurance of established dental colleges be made a function of the DARB.
11. EDRB should be mandated to maintain and make publicly available a live register of students and teachers in dental institutes across the country.
12. It is recommended that the power of the central government which allows it to disregard the suggestions of the NDC under clause 34 regarding establishment of colleges and their recognition be removed from the NDC Bill to ensure autonomy and accountability of the regulator.
13. The provisions requiring the NDC to identify & reward better institutes and develop a graded plan for underperforming dental institutes should be made a part of the NDC Bill.
14. The decision as to whether a question is of policy should be taken jointly by the central government and the regulator. In case of dispute, the power may be kept with the central government with a provision for a written response to the objections by the NDC.
15. The power of the central government to give directions to the NDC and Autonomous board destroy the independent and autonomous nature of the NDC and should be removed completely.
16. A regulator should be primarily funded through the fees it generates. The NDC Act is silent on the principles through which such fees might be charged by the NDC. The principles include, Charging fees only to cover expenses and keep adequate reserves; fees to be charged only through regulations; the regulator should clearly explain demonstrate the proportionality of the fees to the cost to the regulator; and the regulator should break up the fees into different categories.

Preamble

The current preamble states that the purpose of the proposed law is: 

“to provide for a dental education system that improves access to quality and affordable dental education, ensures availability of adequate and high quality dental professionals in all parts of the country; that promotes equitable and universal oral healthcare that encourages community health perspective and makes services of dental professionals accessible to all the citizens; that promotes national health goals; that encourages dental professionals to adopt latest dental research in their work and to contribute to research; that has an objective periodic and transparent assessment of dental institutions and facilitates maintenance of a dental register for India and enforces high ethical standards in all aspects of dental services; that is flexible to adapt to changing needs and has an effective grievance redressal mechanism and for matters connected therewith or incidental thereto” 

The preamble in the current form includes elements of dental education as well as professional regulation, which is an improvement from the earlier preamble of the Dentists Act, 1948 which was focused at regulating the profession of dentistry. 

However, while the preamble of the proposed law lays down the objectives of the National Dental Commission (NDC) in detail, it falls short of recognising the ultimate goal of the NDC, that is, Patient Safety. 

The Dental Council of India is envisaged as an independent regulator of the dental profession and education in India. In 2012, the OECD published its Recommendation of the Council on Regulatory Policy and Governance. The first principle of an independent regulator is the clarity in its role. The principle envisages that an effective regulator must have clear objectives, with clear and linked functions and the mechanisms to coordinate with other relevant bodies to achieve the desired regulatory outcomes. Clarity of purpose helps the regulator be accountable for their actions to the public.

Universally, patient safety is being seen as the ultimate concern of the regulatory bodies. WHO Safety Curriculum envisages effective regulators with the appropriate legislation, resources and tools to sanction unsafe clinician behaviour. 

In India, the Report of Financial Sector Legislative Reforms Commission (FSLRC) is seen to be groundbreaking in conceptualising and defining the role of an independent financial regulator. The FSLRC report states that consumer protection in the financial sector (much like patient protection/safety in the medical sector) is a key regulatory component that can help a regulator to initiate preventive and curative activities for the protection of the consumers (or in the present case, patients). The Commission stated that “As such, the Commission believes that it is essential to place the function of consumer protection at the heart of financial regulation”. 

It is submitted that the draft National Dental Commission Bill, 2020 (NDC Bill) considers patient safety in its objectives in its Preamble. This would make the actions of the proposed NDC accountable to the public. 

Chapter-wise comments 

This section contains comments on select sections of the Bill, arranged in chapter-wise form.

Chapter I Preliminary

Definition of a dentist (Clause 2j) borrows from the definition of dentistry in clause 2k in the present form. It states that "dentist" means a person who practises dentistry. However, this definition is inadequate and does not exclude persons not trained in the field from practising the profession of dentistry. Borrowing from the example of the definition adopted by the American Dental Association and adding the function of promotive oral health, the proposed definition of dentistry is recommended to be as follows:

“The evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; and the promotion of oral health, provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law.”

Definition of dentistry (Clause 2k) should include:

• Measures for promoting dental & oral health
• Measures that include promotive, preventive and curative healthcare for diseases and conditions affecting public health and population health such as oral cancer, HIV. 

As the profession of dentistry is closely linked with ‘Oral Health’, its definition should be added to this chapter. For this, it is recommended that the World Health Organisation definition of Oral Health be adopted. The definition is reproduced below:

“a state of being free from chronic mouth and facial pain, oral and throat cancer, oral infection and sores, periodontal (gum) disease, tooth decay, tooth loss, and other diseases and disorders that limit an individual’s capacity in biting, chewing, smiling, speaking, and psychosocial wellbeing.

The Dentists Act, 1948 included regulation of DHs and DMs under the Dental Council of India. It is suggested that this framework continues in the NDC Bill as the DHs and DMs are an important part of the dental professional framework. The definitions of these professions as set out in the Dentists Act, 1948 be adopted:

“ “dental hygienist” means a person not being a dentist or a medical practitioner, who scales, cleans or polishes teeth, or gives instruction in dental hygiene;” (Section 2(b))

“ “dental mechanic” means a person who makes or repairs denture and dental appliances;”

Chapter II The National Dental Commission

The NDC is proposed to have 30 members under clause 4 of the NDC Bill. This is a significant reduction and a welcome step from the present 95 members in the DCI. 

Twenty two of these members are part-time members to be appointed for a term of two years. The majority of part-time members are nominated from the Dental Advisory Council by the states and Union Territories under the Act. The maximum term of the Chairperson of the proposed NDC will be four years. Under the proposed structure, the composition of the Board will change significantly in the four year term of the Chairperson of the NDC as 22 members will be replaced in the term. FSLRC principles on the appointment conditions on the Board Members state that a fixed-term should be applicable for all members, subject to a retirement age for executive members. This is important because it will enable the Board to function without unnecessary interruptions caused by change in the composition of the Board. Therefore, it is recommended that the duration of part-time members as proposed in the NDC Board be increased to four years, to coincide with the term of the Chairperson under clause 4 of the Bill.

The functioning of the board of regulators should primarily be left to the rules and regulations formed by the regulator. However, in the interest of accountability, certain principles must be laid down to govern the actions of the board. For instance, the NDC Bill prescribes the frequency of meetings of the Board, quorum and the process of decision making (through voting) under clause 9. The provisions under clauses 6(5)(6) and 6(5)(7) help in reducing the chances of conflict of interest as they require members to put information about their assets in a public forum as well as disallows members to obtain employment as consultants in private dental colleges for a cooling-off period of two years. This helps in reducing the chances of the members from taking advantage of their position earlier. However, provisions in this chapter omit prescribing requirements for recording the proceedings of the meetings held by the Board as well as the provision for making decisions without conducting the meetings. These provisions may be added in the text of the Bill. 

Clause 9 of the Bill deals with meetings and functions of the Board. Under clause 9(6), it is prescribed that a person aggrieved by a decision of the NDC can appeal to the Central Government. This provision is unacceptable on the grounds of causing undue influence of the central government on the functioning of the Board. The central government is one of the stakeholders running dental colleges in India. As such, the provision introduces an element of conflict of interest and therefore, should be abandoned. It is recommended that clause 9(6) giving appellate power to the central government over decisions of the Board should be removed in order to reduce the risk of conflict of interest and preserve the autonomy of the NDC. An aggrieved person should be able to approach the courts against any arbitrary and illegal actions taken by the Board. 

Clause 10 of the NDC Bill lays down the powers and functions of the NDC. The NDC is tasked with legislative, executive as well as judicial functions. For instance, the NDC is required to assess the HR and infrastructure requirements in dental health care and lay down policies for the same (legislative), ensure compliance by the State Dental Councils of the guidelines and regulations framed by it (executive) and exercise appellate jurisdiction over autonomous boards (judicial). However, the provisions for accountability from these functions are absent. For instance, the legislative requirements do not include provisions regarding the process to be followed by the NDC to lay down policies which would include describing the scope of the exercise, conducting background research, stakeholders’ interactions, recording reasons for adoption of the policy, assessing alternate mechanisms and costing requirements for the policies, describing methods to execute them as well as the need to update such policies timely.

Including checks and balances is important for the new law as the DCI had faced challenges in performing its functions. Absence of such provisions in the Dentists Act, 1948 made the DCI complacent and its inactions went unnoticed for a long time. A CAG performance audit of the DCI observed that while the DCI was supposed to undertake periodic updates of the dental colleges, it had not designed any system to identify institutes for conducting periodic updates. The report also stated that DCI was also not performing its basic task of maintaining a National Register of Dentists as required by it under law. 

.

For this purpose, the following principles of FSLRC are suggested to be included in the NDC Bill:

• The NDC Bill should ensure that the regulation-making process be overseen by the Board to increase accountability of the Board;
• Process of public participation in regulation-making should be standardised and put in the NDC Bill;
• The NDC Bill should provide for strong executive powers, balanced with greater transparency and accountability, to prevent abuse. For instance, the inspection planning guidelines, inspection reports and action taken reports should be publicly available; and
• Judicial & quasi-judicial functions to be performed by the NDC should follow the proportionality principle. For instance, the NDC could develop a graded system of inspection results for dental schools and its effects on a scale from needs no improvement to recommend derecognition. Derecognition should be recommended in extreme cases and should include a transition plan for students.

Chapter III Dental Advisory Council

The establishment of the Dental Advisory Council (Council) is a welcome step in the regulatory structure of the NDC. The function of the advisory council is to ensure that there is representation from important stakeholders in the decisions taken by the Board. 

While the members of the Council have representation from various states, public and private institutes etc., the NDC Bill has not specified the term for any of its members. A defined term of the advisory council members will ensure that sufficient continuity and turnover of members is maintained to ensure that member’s expertise remains current. 

The functions of the council are provided in clause 12 and include providing views on regulatory functions of the NDC. However, providing views on regulatory functions of the NDC is not mandatory for the council. As providing views on the regulatory functions of the NDC is the only function of the council, it should be mandated to do so.

Therefore, it is recommended that the NDC Bill specify limited or fixed-terms of appointment, extendable to a second term for the members of the Dental Advisory Council. It is also recommended that the functions of the Council mandate creating a report on all draft regulations published by the regulator stating the council’s views under clause 12.

Chapter V Autonomous Boards

The NDC Bill envisages four autonomous boards under the overall supervision of the NDC. These are: 

(a) the Under- Graduate Dental Education Board

(b) the Post-Graduate Dental Education Board

(c) the Dental Assessment and Rating Board; and

(d) the Ethics and Dental Registration Board.

Each of the four boards is setup as an autonomous body and will be comprised of a President, two whole-time members, and two part-time members. The President, full-time members and one-part-time member of Autonomous Boards are to be chosen based on the recommendations of the Search Committee. The remaining part-time members for each autonomous board are elected by various State Dental Councils. Each Autonomous Board will be empowered to take decisions on all matters pertaining to its jurisdiction, and will have complete administrative and financial decision-making powers.

The part-time members of the Autonomous Boards are also eligible for two years of service as was envisaged in the NDC Board. However, their power is significantly reduced as there are no requirements for quorum and decisions of these Boards can take place by a simple majority vote. The role of the part-time members is also crucial because one of these members in all boards are elected from various states. By reducing their term to two years, the NDC Bill shall enable continuous election modes in states. As elections are time-consuming and expensive, as well as the rationale for having part-time members is unclear, it is recommended that the term of all members of Autonomous Boards be made four years to enable the Boards to function without interruptions. 

Just like in the case of the NDC Board, the functioning of the boards should primarily be left to the rules and regulations formed by the regulator. However, in the interest of accountability, certain principles must be laid down to govern the actions of the board. For instance, the NDC Bill prescribes the frequency of meetings of the Board (monthly) and the process of decision making (through voting) under clause 22. However, provisions in this chapter omit prescribing requirements for recording the proceedings of the meetings held by the Board as well as the provision for making decisions without conducting the meetings. These provisions may be added in the text of the Bill. 

Clause 28 of the NDC Bill specifies requirements for establishing new colleges. However, ongoing quality assurance of more established dental institutes is not considered in the functions of the Dental Accreditation and Ratings Board (DARB). Given that a need has been felt for ensuring regular inspection of existing dental colleges in the past, it is recommended that ongoing quality assurance of established dental colleges be made a function of the DARB.

Clause 31 of the NDC puts down requirements for the Ethics and Dental Register Board (EDRB). The EDRB is required to maintain a list of licensed Dentists practising in India in the National Register for Dentists. However, the NDC Bill has omitted the practice of the DCI in registration of students and teachers in the public domain. This was necessitated to increase transparency and accountability of the regulator. It is therefore recommended that a live register of students and teachers be be maintained and made available publicly by the EDRB in lines with the practices followed by the DCI.

Chapter VI Recognition of Dental Qualifications

Clause 34 deals with recognition of dental qualifications by universities and institutions in India. The Under-Graduate & Postgraduate Dental Education Boards are responsible for the recognition. This provision also deals with the quasi-judicial functions of the NDC. Currently, as per the NDC Bill, an appeal against any decision of these Autonomous Boards is to be preferred to the NDC in the first instance. Further, if aggrieved by any decision of the NDC, a final appeal lies to the central government.

Therefore, the central government has final appellate jurisdiction under the NDC Act.

It has been seen in the past that the central government had established dental colleges despite the disapprovals of the Dental Council of India without giving appropriate reasoning for such actions. Therefore, there are chances of irregularities by the central government in the present situation as well. It is recommended that the power of the central government to disregard the suggestions of the NDC be removed from the NDC Bill to ensure autonomy and accountability of the regulator

Clause 37 of the NDC Bill deals with withdrawal of recognition granted to established dental institutes in India. The clause gives powers to the NDC to withdraw the recognition of an institute if the standards prescribed by the autonomous institutes are not met by the institutes. The NDC is also mandated to undertake consultations with the stakeholders before concluding this process. Two considerations seem to be missing from this framework. The first consideration is the introduction of identification and rewarding better institutes and the second is envisaging a graded response to deteriorating quality of dental institutes. Just like sanctions for poor performing and non-complying dental institutes are necessary, there should also be a reward for colleges that perform well. The rewards can be greater autonomy to the institute for performing its functions like, in introducing new learning techniques. Similarly, instead of recommending withdrawal of recognition to underperforming dental institutes, the regulator should be mandated to introduce a method of collaborating with the institute to increase its standards. The regulator should hand-hold such institutions unless they are identified as non-recoverable. However, a graded response from the regulator is necessary given that the costs of establishing a dental college are exponential as well as derecognition could have negative impacts on the students enrolled in the institute. The provisions requiring the NDC to identify & reward better institutes and develop a graded plan for underperforming dental institutes should be made a part of the NDC Bill.

Chapter VIII Miscellaneous

Clauses 44-46, 53-54 in this chapter deal with the powers of the central government under the NDC Bill. The central government has the power to give directions to the NDC as well as the Autonomous Boards with respect to questions of policy. The decision as to whether a question is one of policy or not is to be taken by the central government itself and will be binding on the commission. The central government will have a supervisory role in as much as the NDC would be responsible for submitting its minutes, reports, abstracts of accounts and other information to it. Similarly, the rules under the NDC will be made by the central government. It also has been given powers to supersede the NDC. 

A regulator is an agent of the government. The government is expected to reasonably oversee the functions of the regulator. However, there is a corresponding risk of encroachment on the powers and functions of a regulator by the government. In order to minimise such a risk, the NDC Bill should assure the autonomy of the Commission while ensuring accountability to the central government. For this, the following is recommended:

1. The decision as to whether a question is of policy should be taken jointly by the central government and the regulator. In case of dispute, the power may be kept with the central government with a provision for a written response to the objections by the NDC.
2. The power of the central government to give directions to the NDC and Autonomous board destroys the independent and autonomous nature of the NDC and should be removed completely.
3. A regulator should be primarily funded through the fees it generates. The NDC Act is silent on the principles through which such fees might be charged by the NDC. The principles include charging fees only to cover expenses and keep adequate reserves; fees to be charged only through regulations; the regulator should clearly explain demonstrate the proportionality of the fees to the cost to the regulator, and; the regulator should break up the fees into different categories.