July 4, 2023
Good morning. In today’s either/view, we discuss whether the drug regulation draft Bill is enough to redeem India’s global pharma standing. We also look at the bird census in Bihar, among other news.
📰 FEATURE STORY
Is the drug regulation draft Bill enough to redeem India’s global pharma standing?
India has long been a prominent player in the global pharmaceutical industry. But it doesn’t have a clean slate in quality drug manufacturing. The “Pharmacy of the World” has more than a few skeletons in its closet. And it all came to light when other countries began reporting deaths and debilitating side effects after consuming Indian drugs. What was the government to do?
The Centre introduced the New Drugs, Medical Devices, and Cosmetics Bill in 2022. It was brought to replace the Drugs and Cosmetics Act of 1940 and overcome its limitations. It addresses critical issues such as e-pharmacy, Ayurveda regulation, and clinical trials. But does it pack the punch needed to revamp India’s pharmaceutical industry?
Context
India’s drug industry is worth a massive $42 billion. According to rating agency Care Ratings, it’s projected to be $60.9 billion by the end of this year. By 2030, it’s expected to increase to $130 billion.
India’s generic drugs account for 20% of the world’s global supply. These are cheaper than brand-name drugs but contain the same active ingredients and are meant to work in the same way in terms of effectiveness, safety, and quality.
They are less expensive because different pharmaceutical companies make them once the patent protection for the brand-name drug expires. Still, they’re expected to undergo strict testing and regulatory approval to ensure they are safe and effective. The Indian pharma industry is the largest producer of generic drugs worldwide.
But a bigger market share beckons bigger problems.
Last year, the industry caught the world’s attention for all the wrong reasons. Sixty-six children in Gambia died after ingesting cough syrup manufactured by Maiden Pharmaceuticals. Then came news of 18 children’s deaths in Uzbekistan after ingesting Marion Biotech’s cough syrup.
The Central Drugs Standard Control Organisation (CDSCO) revoked the company’s license, and the government initiated a probe. But the findings are the Ministry of Health and Family Welfare’s closely guarded secret since they are yet to reveal it.
In Jammu and Kashmir, a similar fate struck 17 children who consumed cough syrup made by Digital Vision. The incident was caused due to high levels of diethylene glycol (DEG) present in the medicines. Since 1972, there have been at least five major DEG poisonings in the domestic market.
Ranbaxy Laboratories, a generic drugmaker, faced legal consequences and hefty fines for not just distributing adulterated drugs but also falsifying data from its facilities.
Even during the COVID-19 pandemic, fake vials of remdesivir flooded the market. Shockingly, 20% of pharmaceutical products sold in India are estimated to be counterfeit. Quality control issues and non-compliance with manufacturing practices are some other problems in the industry.
Despite many cases of negligence and failed quality management, India has barely made a dent in the damage control department. You see, license suspensions are merely a bandaid – a temporary fix.
Ideally, criminal trials are launched in such cases. But India’s Drugs and Cosmetics Act of 1940 has proven an outdated and insufficient regulatory measure. One problem is that it has created a confused and overlapping infrastructure of multiple state-level and central authorities, apart from CDSCO, to look after the industry.
A major communication gap defines the relationship between state-level authorities and the Centre. Experts lament the complacency that pervades the implementation of the drug law. The law fails to cover the vast needs of the modern pharmaceutical industry. Recognising this, the Union health ministry published a new draft Bill called the New Drugs, Medical Devices, and Cosmetics Bill, 2022.
India’s pharma industry needs to work its way back to being a credible pharmacy supplier. Is the draft law up to the task?
VIEW: It checks the right boxes
The Centre recognises that India’s pre-independence era law is incompatible with and of little help in the modern pharmaceutical industry. For instance, NITI Aayog highlighted that the law in place doesn’t include medical devices, a burgeoning segment of the pharmaceutical industry. And the CDSCO? It isn’t really fit to check medical devices. The new Bill was drafted with a special emphasis on this.
It addresses two major afflictions of the pharma industry: e-pharmacies and Ayurveda regulation. It endows the Central government with the authority to oversee and regulate this sector. A new committee called the Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy Drugs, Medical Devices, and Cosmetics Consultative Committee will look after this.
The draft reflects the severity of the old law, especially regarding clinical trials. It introduces strict penalties, including imprisonment of up to ten years, which could even extend to a life sentence, along with fines of up to ₹15 lakh. It prohibits conducting clinical trials without prior permission from the Central Licensing Authority.
COUNTERVIEW: It’s a step backward
Legal and medical experts opine that the proposed Bill of 2022 falls short of expectations. It’s more or less a replica of the current antiquated legislation. It doesn’t establish a regulatory mechanism that ensures the health and safety of citizens and that the industry becomes globally competitive. The absence of an independent, statutory regulator is a key criticism. The Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board are insufficient in streamlining regulation and enhancing effectiveness.
The new Bill doesn’t mention good manufacturing practices (GMPs) at all. Most countries now follow the rigorous GMP system. Although introduced in India in 1988, they were never prioritised. Unlike the United States, Indian law lacks criminal penalties for non-compliance with GMPs, and inspection reports aren’t published, leading to concerns about the effectiveness of inspections. Failure to adhere to internationally-recognised standards impedes the growth of the pharma industry’s exports.
The Bill isn’t stringent against adulterated or substandard quality drugs as it appears on the face of it. Under Section 71 of the proposed draft Bill, the prosecuting drug controller can waive a trial and prison sentence if the accused pharmaceutical company agrees to pay the fine. In this sense, it decriminalises malpractice, something the existing law, despite its implementation defects, holds accountable through tough measures.
Reference Links:
- India’s massive pharma industry hounded by scandals – DW
- Why are Indian drugmakers under the lens? – The Hindu
- Few inspectors, no records: Drug regulation in India is hobbled by a number of problems – Scroll
- Ranbaxy to pay $500 mn to US Department of Justice for settlement of felony charges related to drug safety – The Economic Times
- Comments on the Drugs, Medical Devices and Cosmetics Bill, 2022 – Vidhi Centre for Legal Policy
- Explained: Why Is the New Drugs Regulation Bill Being Criticised? – The Quint
What is your opinion on this?
(Only subscribers can participate in polls)
a) The drug regulation draft Bill will help redeem India’s global pharma standing.
b) The drug regulation draft Bill will not help redeem India’s global pharma standing.
🕵️ BEYOND ECHO CHAMBERS
For the Right:
What the Clutch of Conmen Faking Links to the PMO Says About Modi’s Governance Style
For the Left:
BJP’s Maharashtra metaphysics: Let’s talk power, and then Pawar
🇮🇳 STATE OF THE STATES
Apple output affected (Himachal Pradesh) – Due to reduced production, the prices of apples in the state are expected to rise. Increased rainfall and snow have affected production, with experts suggesting a 50% decline in the state’s output. This could lead to a 30-60% rise in prices. The current yield from the state is only 7-8 metric tonnes. The government also recently reduced import duties on apples from the US which has concerned local farmers.
Why it matters: Despite an increase in cultivated area over the past decade, extreme weather events have adversely impacted apple production. In 2010, it was 1.01 lakh hectares. In 2020 it was 1.14 lakh hectares. The low production numbers point to the state needing to adopt modern techniques to increase output. The state usually accounts for over 26% of the country’s apple production.
Success of microfinance (Tamil Nadu) – Tamil Nadu is regarded as the first state to recover from the pandemic and regularise microfinance payments. Access to collateral-free microcredit is helping generate employment opportunities across the state. Microlender Spandana Sphoorty Financial Limited recently announced adding 90 branches. The Bengaluru-based CreditAccess Grameen Limited has the largest number of branches in Tamil Nadu, with 378.
Why it matters: By having access to microfinance credit, the role of private money lenders, who charge high interest rates and fees, can be reduced. It also gives people an opportunity to access higher loan amounts from other institutions. The state’s credit culture is one reason the microfinance market has thrived. It’s also having an effect on urban areas.
Bird census (Bihar) – 205, that’s the number of bird species found thanks to a new bird census conducted in Bihar by the Department of Forests, Environment and Climate Change, and the Bombay Natural History Society (BNHS). The survey was done across 26 districts and covered 76 wetlands in three river systems – Ganga, Kosi, and Gandak. During the winter, there are a greater variety of migratory birds that visit the wetlands.
Why it matters: Since last year, the government has carried out the census to review their numbers and habitats and create awareness about their conservation. In 2021, the forest department organised Karlaw, a bird festival at the Nagi bird sanctuary. In 2018, the Centre started India’s National Action Plan for Conservation of Migratory Birds and their Habitats, where states were asked to help in bird conservation.
Showcasing maritime history (Gujarat) – An MoU was signed between the Ministry of Ports, Shipping and Waterways and the Ministry of Defence to develop a Naval Gallery at the National Maritime Heritage Complex (NMHC) in Gandhinagar. The museum will come up in the Lothal region. The museum will showcase India’s diverse maritime heritage and legacy and is one of the major projects under the Ministry of Ports, Shipping, and Waterways.
Why it matters: The museum is expected to be the biggest maritime museum complex. The facility will also be a centre of learning to understand India’s maritime history. The entire complex will also have a lighthouse museum and a theme park. Since it’s located in the historic Indus Valley Civilisation region, it will also have galleries of maritime heritage starting from the Harappan times.
AAP’s electoral plans (Arunachal Pradesh) – As the state goes to the polls next year, the AAP’s state unit is outlining its plans. It includes fielding candidates in all 60 assembly constituencies and a few Lok Sabha seats. Among the promises are free water, power, and healthcare up to ₹10 lakh. The party also promised to repeal the controversial 2014 Arunachal Pradesh Unlawful Activities (Prevention) Act and the Arunachal Pradesh District-Based Entrepreneurs and Professionals (Incentives, Development, and Promotional) Rules of 2015.
Why it matters: The party had set its sight on the northeast following its win in Punjab. It aims to bring back honest politics to the region which began with the Guwahati civic polls. The party hopes to replicate its populist governance model of Delhi and Punjab in the region. As its plans took shape last year, it was bolstered by members joining from Congress and Assam’s Raijor Dal.
🔢 KEY NUMBER
$289 million – Women-led startups in India raised only $289 million in the first half of this year. It’s a 88% decline compared to $2.4 billion for the same period last year.