Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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New Delhi, India-May 4 2018: Supreme court of India building in New Delhi, India.

The Supreme Court of India’s Landmark Abortion Ruling, Explained

By Aparajita Lath

The Supreme Court of India recently ruled that all women, whether married or not, have equal rights to access abortion up to 24 weeks of gestation, in compliance with the provisions of the Medical Termination of Pregnancy Act, 1971 (MTP Act).

Prior to this ruling, the MTP Act was understood to permit abortions up to 20 weeks (on the advice of one medical practitioner), and up to 24 weeks in certain specific cases, e.g., minors, pregnancies resulting from rape, women experiencing changes in marital status, women with certain mental / physical disabilities, fetal malformation, or pregnancies in emergency situations. The Supreme Court has now expanded the law to ensure access to abortion for all women, regardless of marital status, up to 24 weeks gestation.

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Tilpath Valley Biodiversity Park spreads over an area of 69.56 ha on the Southern Ridge that is contiguous with Aravalli ranges of Haryana, in south Delhi, New Delhi India.

Proposed Amendments Would Make Foreign Investment in India’s Biological Resources Easier

By Aparajita Lath

Indian lawmakers are currently debating proposed amendments that would make it easier for foreign investors to research and develop products from native biological resources, such as plants.

India is one of the 17 internationally recognized mega biodiversity countries, and hosts four of the 35 globally recognized biodiversity hotspots.

Since countries have sovereign rights over their biological resources, Indian companies enjoy easier access to and use of these biological resources for various commercial applications, including pharmaceuticals, cosmetics, and biotechnology. Foreign companies and Indian companies with any foreign participation in share capital or management are strictly regulated.

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Disability with technology line icon set.

Reflecting on the Struggle for Disability Rights a Year into the Pandemic

By Amalia Sweet

On March 9, the Petrie-Flom Center and Harvard Law School Project on Disability gathered a panel to discuss the extent to which the pandemic has set back progress toward ensuring the rights of persons with disabilities.

Though calls for solidarity in March 2020 declared the emerging pandemic to be a “great equalizer,” the past 12 months have demonstrated how the pandemic has exacerbated existing social inequalities, disproportionately impacting the already marginalized.

The panel discussion, hosted by Petrie-Flom Center Senior Fellow in Global Health and Rights Alicia Ely Yamin and moderated by Harvard Law School Project on Disability Executive Director Michael Ashley Stein, provided voice to the uniquely and acutely devastating impacts of the pandemic on persons with disabilities, who are still struggling to secure protection of their basic rights.

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Delhi, India.

COVID-19 in India: Lockdown, Legal Challenges, and Disparate Impacts

By Anand Grover

With only four hours’ notice, the Government of India imposed a nationwide lockdown to combat COVID-19, which began on March 24th, 2020 and is scheduled to end on May 17th, 2020.

The lockdown was implemented through executive orders, beginning March 24th, 2020, together with guidelines under the Disaster Management Act (DMA).

Only essential services, such as those related to security, government, food, medical supplies, and municipal cleaning, were permitted to continue operations, albeit sometimes in a curtailed manner. Inter-state and district borders were sealed. All persons, except those engaged in essential services, were mandated to stay at home and observe social distancing. Testing, quarantine and contact tracing were employed to detect and prevent further transmission of the virus. Breach of orders was criminally punishable.

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a pill in place of a model globe

When it comes to opioids, it’s all about turf.

By Stephen Wood

When it comes to selling opioids, turf matters. Access to customers and geography play a role in the day to day sales of opioids. This often means selling in areas where there is a wanting and willing customer base with funds to spare. It also means picking a spot, a corner, where enforcement is low or where corruption can overcome most legal problems. The delivery can’t be too conspicuous. It needs to be hidden from plain sight, done in the shadows or alleyways where no one is looking. It’s a craft and when done right can lead to fistfuls of cash in the hands of the distributor, the dealer.

This may sound like a street-level drug deal, but it isn’t. It’s the tactic many American pharmaceutical companies are taking in response to increased regulation on prescription opioids. Like the stealth and shadowy moves of a street-level dealer, American pharmaceutical companies have moved their turf to new, mostly naïve markets to sell their wares. They have done this to escape the federal regulations that have limited their market; a response to the opioid crisis that has seen hundreds of thousands of lives affected by substance use disorder or lost to overdose.

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Big relief for Big Pharma: Indian Patent Office rejects application for compulsory license

Aditya Gupta

By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out a prima facie case for grant of a compulsory license since it had not made efforts to obtain a voluntary license from BMS on reasonable terms and conditions.

Though the Indian Patent Office did not go into the merits of BDR’s application and rejected it on preliminary grounds, this victory will help restore pharmaceutical companies’ faith in the Indian patent system.

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