Editorial 1:Regulatory reform stuck in a loop in Health Ministry
Context
The policy initiatives of recall guidelines, good distribution practices and the use of similar brand-names either lack the force of law or are poorly thought through.
Introduction
Earlier this year, the Drugs Controller General of India (DCGI), working under the direct control of the Ministry of Health and Family Welfare, announced policy initiatives on three issues: recall guidelines, guidelines on good distribution practices and the use of similar brand-names by pharmaceutical companies for their drugs.
The need for guidelines
All three measures have a direct impact on public health.
- Recall guidelines are meant to swiftly remove drugs that fail testing in government laboratories from the market.
- The guidelines on good distribution practices are meant to regulate how drugs are stored and distributed during transit and sale.
- The measure against confusing brand names is aimed at preventing prescription errors, wherein wrong drugs are dispensed to patients causing them harm.
Unfortunately, these measures either lack the force of law or are poorly thought through. For over a decade, we have seen this old wine of vague guidelines and cautionary letters sold to us in a new bottle, disguised as concrete measures of reform.
The 59th report of the PSC
The 59th report of the Department Related Parliamentary Standing Committee on Health & Family Welfare (PSC) which was tabled in 2012. The findings were:
- Gaps In drug regulation and oversight by CDSCO: This report, which focused on how the national drug regulator, the Central Drugs Standard Control Organisation (CDSCO) functions, the PSC raised a host of issues including the lack of recall guidelines, the lack of standards for storage of drugs and the problem of confusing brand drug names.
- The lack of recall guidelines: Was flagged during a meeting of the Drugs Consultative Committee (DCC) back in 1976 when State drug controllers realised that drugs ordered to be withdrawn in one State due to quality concerns were being sold in a neighbouring state.
- The lack of proper standards for storage of drugs: especially during transportation, was flagged by the Supreme Court of India in 1974, in Swantraj & Ors vs State Of Maharashtra.
- Confusion between brand names: Similarly, the issue of similar brand names for different drugs was flagged by the Court in 2001 in Cadila Healthcare Limited vs Cadila Pharmaceuticals Limited.
- Impact of PSC repots: When the PSC raised these very issues in its 59th report, it created significant pressure on the Ministry of Health because it demanded follow-up action.
- Lack of ministerial reforms: The PSC even published a scathing “Action Taken Report” the following year indicating its unhappiness with the lack of effective reform by the Ministry of Health.
- Unfortunately, these issues raised by the PSC over a decade ago are yet to be tackled effectively and have been stuck in a loop at the Ministry of Health, since the bureaucracy is either unable or unwilling to tackle these issues.
Non-binding guidelines in a loop
- Lack of drug recall guidelines: For example, the most recent drug recall guidelines announced in August by the DCGI were in fact first announced in the year 2012 after the PSC report was tabled and then again in 2017.
- Lack of legal power: In all three instances, the initiative for drug recall guidelines came from the office of the DCGI, except that the DCGI lacks the legal power to make rules that are binding and have the force of law. Only the Ministry of Health has that power under the Constitution.
- No Action taken for breach of standards: As a result, 48 years after the lack of recall guidelines was first identified at the DCC, India continues to have these guidelines which cannot be legally enforced and the breach of which have no legal consequences. It is no wonder then that we never hear of action removing ‘not of standard quality drugs’ from the market.
Guidelines for storage and transfer of drugs
The story with the guidelines to regulate the storage of drugs during transit and sale is even more depressing.
- Proposal for good distribution practices: Came up after the PSC report, a formulated by the World Health Organization (WHO) came up for discussion at the meeting of the DCC in 2013.
- The proposal at that time was to make good distribution practices guidelines legally binding.
- Difficulty in implementation: However, this proposal was opposed within the DCC because it was felt that it would be too “difficult to implement” across the estimated six lakh retail outlets in the country —
- the DCC likely anticipated pushback from trade associations of pharmacies since the good distribution practices guidelines would require investments in storage equipment.
- This reluctance to make good distribution practices guidelines mandatory was a dereliction of duty toward public health because India is a hot and humid country.
- Improper quality infrastructure and standards: In many parts of India, especially during summer, drugs are guaranteed to degrade without proper temperature and humidity controls.
- Poor storage practices: In 2019, the GDP guidelines were back on the DCC’s agenda after a raid at the wholesale market for medicine at Bhagirath Palace, New Delhi revealed shockingly poor storage practices for drugs, including vaccines.
- Making a binding law: This time though, the DCC resolved to make good distribution practices guidelines into binding law.
- Unfruitful consultation rounds: Instead of proceeding to declare the guidelines as binding law, the government has once again decided to conduct, thereby further delaying the implementation of WHO standards.
The issue with the confusing brand names
The story with confusing brand names follows a similar trajectory.
- Lack of action taken: Despite being flagged by the top court in 2001 and the Parliamentary Standing Committee in 2012, the government did nothing to fix the problem.
- Supreme courts’ intervention: After receiving a rap on its knuckles from the Delhi High Court in 2019, the government introduced an entirely useless legal rule to address this issue.
- Ministry’s intervention: Instead of creating an obligation upon the regulator to vet the brand names before a drug could be marketed, the Ministry created a rule requiring pharmaceutical companies to provide a self-declaration that their proposed brand name was not similar to any of the existing brand names in the market.
- Global cases: In most other countries, it is the duty of the regulator to vet the brand name, to ensure that it is not confusing or misleading from a public health perspective.
- Issues with self-regulation: It makes no sense to ask the pharmaceutical industry to self-regulate on this issue as evidenced by the large number of confusing pharma brand names in India even after these rules came into force.
- Intervention from NHRC: Earlier this year, after we wrote about the issue in this daily, the National Human Rights Commission (NHRC) intervened and issued notice to the Ministry of Health.
- The Directorate General of Health Services (DGHS) response: It wrote a letter to the Registrar of Trademarks asking to ensure that confusing trademarks were not registered.
- Gaps missed by DGHS: The DGHS completely misses the point that trademark registration is voluntary.
- Many companies do not seek to register their brand names as a trademark.
- Even when trademark applications are filed, the Registrar of Trade Marks conducts a perfunctory “confusion analysis” that does not include a public health perspective.
- Thus, Brand names should ideally be scrutinised by the regulator for being misleading and fanciful from a health perspective.
Way forward: Breaking the loop
The three reform measures discussed here are reflective of a consistent leadership failure in the higher echelons of the Ministry of Health. Matters pertaining to drug regulation are meant to be guided by a joint secretary heading the Drug Regulation Section in the Ministry. This officer, who usually hails from the All India Services, holds the post for a few years before moving on to the next posting. She has little domain expertise in this area and lacks the institutional knowledge that policymaking requires. This expertise needs to be expanded and more experienced and professional members can be bought onboard to make and steer policies.
Conclusion
An assumption is that with every newly appointed joint secretary, these files go through with repeated consultations with stakeholders in the pharmaceutical industry. In each of these consultations, the trade associations of pharmacies and pharmaceutical companies use every trick in the book to stall the necessary action and the bureaucracy uses a familiar playbook of repeat consultations to stall concrete action. We need to take proactive steps to break the loop will be broken the direct intervention of the Prime Minister’s Office. The more efforts towards a comprehensive approach will help in finding the right solutions.
Editorial 2: Next Census should be the last enumeration-based one
Context
There are strong reasons why India needs to have ‘register-based’ and ‘dynamic’ census.
Introduction
According to media reports, India is likely to begin conducting the long-delayed Census exercise and complete the survey within 18 months. So, realistically, the final Census report might be available sometime in late 2026 or in 2027, with a roughly 16-year gap since the last Census of 2011. The COVID-19 pandemic, however, is cited as the primary reason for the delay in the census.
Indian population dynamics
- Demographic changes: As per a United Nations report, in the interim, India surpassed China in population. There have been significant changes in the demographics too.
- Hauz Khas, a posh neighbourhood in southern Delhi with affluent urbanites, was partly designated as rural in 2011, for example.
- Lack of proper datasets: While many people are worried that India has been operating without proper data for a long time, in today’s world, there remains a significant discrepancy between reality and the data available, even for a decennial census.
- Long delays: This discrepancy is especially noticeable as the decade-long gap draws to a close. In actuality, the decennial format of most censuses was merely a compulsion because conducting a census is a mammoth and prohibitively expensive undertaking.
- Importance of a census exercise: It certainly makes sense that if census exercises were conducted more frequently, a number of policies and their execution as well as socioeconomic and health-related studies, might be dynamically adjusted by observing the findings.
An idea to pursue
- Readily available data: The “register-based” and “dynamic” censuses, could furnish up-to-date census data whenever needed.
- Realtime updating of data: The database would be updated continuously in real-time during a “dynamic” census.
- Automated Voter Registration System Proposal: Reportedly, a few years ago, India was preparing software by which the birth date of a child will come into the back end of the database of the Census Register, and after attaining the age of 18 years, this person would be registered as a voter in the voter list from the Office of the Census Registrar. The name would be removed from the voter list upon death.
What are the global trends
- Dynamic database: This could be a significant leap in the direction of a dynamic database. However, India’s next Census, which will be the nation’s first “digital census”, may be a complete enumeration.
- Countries having Register-Based Censuses: On the other hand, a number of countries, including Austria, Bahrain, Denmark, Finland, Germany, Greenland, the Netherlands, Singapore, Sweden and Switzerland, are currently moving towards register-based censuses.
- It produce useful statistics primarily from government sources using data from various administrative registers, which includes population, tax, employment, school, hospital records, and data from municipalities.
- Complemented by some well-planned small-scale sample surveys such as those conducted in Switzerland with 5%-10% of the population.
- Cost-effectiveness: Even the United States and the United Kingdom are moving towards register-based censuses. Unsurprisingly, such a census exercise will be cost-effective too.
- For instance, the cost of the 2001 Census in Austria was €72 million.
- However when the register-based approach was implemented in 2011, the cost fell to €10 million.
- Change in stance for UK: The United Kingdom government declared in 2014 that statistics derived from more frequent and timely administrative data will take the place of the decennial census after 2021.
- In place of the customary questionnaire-based approach, the U.K. will harvest the data people leave behind in their everyday lives.
- It is actually a “dynamic register-based census”, meaning that every pertinent social, economic, and demographic activity and event in people’s lives is constantly added to the census database.
- Further, in order to produce its official figures, the Office for National Statistics in the U.K. has recently begun to gather more data — reliable data, of course — even from private companies.
- Examples of this include data collected from supermarket scanners and data on cars and trains from Auto Trader and the Rail Delivery Groups.
- India’s approach: already has an Aadhaar-centric database, unlike the U.K.. And, reportedly, a few years back, the Home Minister asked officials to devise a strategy to merge the voter card, Aadhaar card, and other databases into the Census database.
Way forward: Database integration
However, combining many registers is never a simple operation. Even though it has been increasingly customary in India recently to integrate databases such as Aadhaar, PAN, voter ID, bank accounts, and mobile numbers, it is still a mammoth task to solve the jigsaw puzzle and to build up the “elephant” by correctly assembling different types of “registers”. The nation has sufficient expertise to accomplish that. And, by using the administrative data of various available registers instead, thousands of crores of rupees can be saved.
Conclusion
A census serves as a valuable repository of data pertaining to various economic endeavours, educational attainment and literacy rates, housing and domestic facilities, urbanisation, migration, mortality, fertility, religion, language, and additional socio-economic, cultural, and demographic information. It is unclear if our intended method will be able to update data on the majority of these aspects in real time. Naturally, if any data is lacking, it can be updated on a regular basis by properly conducting surveys, perhaps on a small scale. This approach could make way for dynamic, continuous censuses, which can potentially become a key legacy of Digital India if implemented successfully. The upcoming Census may be India’s final enumeration-based one.
