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9th May 2023

The lack of a drug recall law in India

Context
  • Abbot, a multinational pharmaceutical company, published a public notice in newspapers to alert people about a mislabelled batch of medicine that it had inadvertently shipped to the market.

Key-highlights

  • Since 1976, India has been considering enacting a mandatory recall law for defective medications; however, no such law exists to this day, requiring such medicine to be removed off the market.
  • People, including children, are probably likely dying or suffering from bad health consequences as a result of poor pharmaceuticals remaining on the market for too long.
  • Hundreds of medications flunk random testing in government laboratories every month.

Is there a drug recall law in India?

  • The difference in behaviour between India and the U.S. is due to the lack of a mandatory recall law for substandard drugs.
  • In 1976, the Drugs Consultative Committee discussed the issue of drug recalls, but no law exists that mandates such medicine be removed from the market.
  • Since then, the issue has come up repeatedly in regulatory meetings, but none of them resulted in amendments to the Drugs and Cosmetics Act to create a mandatory recall mechanism.
  • In 2012, certain recall guidelines were published by the CDSCO, but they lacked the force of law.

Why is there no recall law?

  • The Drug Regulation Section of the Union Health Ministry is not up to the task of tackling complex drug regulatory issues due to apathy, lack of expertise and a greater interest in enabling the growth of the pharmaceutical industry.
  • India's highly fragmented regulatory structure, with each State having its own drug regulator, makes it difficult to create an effective recall mechanism.
  • India's drug regulators are aware that a mandatory drug recall system will bring public attention to the state of affairs in India's pharmaceutical industry.

What happens when substandard drugs are not recalled?

  • People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
  • Every month, dozens of drugs fail random-testing in government laboratories. Ideally, these drugs will be necessarily recalled in a transparent manner, with the people being informed of the failures.
    • If this were to actually happen in India, the people would be flooded with alerts on an almost daily basis, which then would increase the pressure on drug regulators to institute extensive reforms.
    • If the bureaucracy’s intention is to avoid accountability, it might prefer to keep quiet and let substandard drugs, even those with dangerous consequences for consumers, circulate in the market.
  • This has been their modus operandi for decades, until recently, when drug failures overseas brought attention to this issue. Yet nothing has changed on the ground.

What are the regulations to curtail misleading food ads?

Context
  • Food Safety and Standards Authority of India (FSSAI) has reported 170 cases of misleading claims and advertisements in the last six months.

Key-highlights:

  • The Advertisement Monitoring Committee at the FSSAI flagged 32 fresh cases of food business operators (FBOs) making misleading claims and advertisements.
  • According to CEO and Secretary General at the Advertising Standards Council of India (ASCI), most complaints of misleading ads were related to the nutrition of a product, its benefits and the ingredient mix not being based on adequate evidence.
  • The FSSAI wants advertisements and claims to be “truthful, unambiguous, meaningful, not misleading and help consumers to comprehend the information provided”.

What are the regulations?

  • The Food Safety and Standards (Advertising & Claims) Regulations, 2018 and the Central Consumer Protection Authority (CCPA) regulate misleading advertisements and claims.
  • The FSSAI seeks to ensure that advertisements and claims are truthful, unambiguous, meaningful, not misleading, and scientifically substantiated.
  • Product claims suggesting prevention, alleviation, treatment or cure of a disease, disorder or particular psychological condition are prohibited unless specifically permitted under the FSS Act, 2006.

When can a product be referred to as ‘natural’ and ‘fresh’?

  • Natural foods products must be derived from a recognised natural source and have no added chemicals or preservatives.
  • Composite foods cannot be called ‘made from natural ingredients'.
  • Fresh products must not be processed.
  • Those with additives may use 'frozen from fresh'.

What about ‘pure’ and ‘original’?

  • ‘Pure’ is to be used for single-ingredient foods to which nothing has been added and which are devoid of all avoidable contamination, while unavoidable contaminants are within prescribed controls.
  • ‘Original’ is used to describe food products made to a formulation, with a traceable origin that has remained unchanged over time.
  • They do not contain replacements for any major ingredients. It may similarly be used to describe a unique process which has remained unchanged over time, although the product may be mass-produced.

What about ‘nutritional claims’?

  • Nutritional claims can be about the specific contents of a product or comparisons with other foodstuffs.
  • The Chief Executive Officer and Secretary General at the Advertising Standards Council of India (ASCI) believes that most complaints of misleading ads are related to the nutrition of a product, its benefits and the ingredient mix not being based on adequate evidence.
  • The claim data should be based on technical data, such as evidence to substantiate that there is Vitamin D in the product.

In new ‘Quad’ meet with U.S., Saudi Arabia, UAE, Doval discusses infrastructure plans in Gulf

Context
  • Recently, Saudi Prince and Prime Minister hosted a special conference of the National Security Advisers (NSAs) of India, the United States, and the United Arab Emirates (UAE) to facilitate Gulf infrastructure initiatives.

Key-highlights:

  • During the conference, Quad members discussed ways to expand bilateral connections and linkages in order to boost growth and stability in the Gulf region.
  • According to a U.S., the meeting sought to “advance their shared vision of a more secure and prosperous Middle East region interconnected with India and the world”.

Counter to China

  • The quadrilateral meetings on infrastructure were meant to provide a counter to China’s Belt and Road Initiative.
  • The project is a plan to connect Gulf countries via a railway network and connect to India via shipping lanes from “two ports” in the region.

Xi Jinping to host first meet with all Central Asia leaders

Context
  • China is hosting a summit with Central Asian leaders to increase its influence in the region.

Key-highlights:

  • The summit in the historical Silk Road city of Xi'an is the first of its sort since diplomatic relations were established 31 years ago with the demise of the Soviet Union.
  • The summit will be attended by leaders from Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan.
  • The conference will concentrate on improving economic and diplomatic ties with Beijing.
  • China has spent billions of dollars to tap Central Asian natural gas reserves.
  • Rail links connect China to Europe and are critical to the achievement of China's trillion-dollar global development initiative, the Belt and Road Initiative.

Russian influence

  • Since the mid-nineteenth century, the Central Asian republics have been ruled by Moscow as part of the Soviet Union.
  • However, since its invasion of Ukraine, Russia's authority has been increasingly challenged, with Beijing courting Moscow's traditional friends in the region.

Five more cheetahs to be released into wild at Kuno

Context

According to the Union Environment Ministry, five more cheetahs (three females and two males) would be released from the Kuno National Park (KNP) acclimatisation camps into "free-roaming conditions" before the monsoon rains arrive.

Key-highlights:

  • The National Tiger Conservation Authority (NTCA) is the nodal body for Project Cheetah.
  • Twenty cheetahs have been brought from Namibia and South Africa since September 2022 to reintroduce them into Indian habitat.
  • Two of the animals have died, but the long-term plan is to gradually release the animals into the wild and keep adding more until a self-sustaining population is established.
  • Four of the cheetahs have already been released into the wild, but the remaining cheetahs will remain in the acclimatisation camps for the duration of the monsoon season.

Concern about space and prey

  • Independent experts have raised concerns that the cheetahs brought in from Africa have too little space and limited access to prey in the KNP.
  • The available space in the park is adequate for 21 cheetahs, but the actual number of animals that the reserve can accommodate can only be assessed after the animals are released and have established home ranges. There is no useful spatial ecology data for cheetahs in India yet.

Chinese boats cross Indian and ASEAN ships during military exercise

Context
  • Boats from a Chinese maritime militia recently approached an area where the Navies of India and ASEAN countries were taking part in drills in the South China Sea.

Key-highlights:

  • According to a Vietnamese independent analyst, Beijing appeared to be deploying the militia to frighten and disrupt the naval drill.
  • The two-day sea phase of the ASEAN-India Maritime Exercise (AIME 2023) was attended by navy ships and aircraft from India, Vietnam, Thailand, the Philippines, Indonesia, and Brunei.
  • When the Chinese boats approached them, they were in the Vietnamese Exclusive Economic Zone.
  • A Chinese research vessel was also heading in the same direction as these boats.

Editorial

Buddhism, India’s soft power projection tool

Context:

There is much significance to India having hosted a two-day global Buddhist summit in New Delhi (April 20-21).  The summit was a significant opportunity for India to project and connect with the Buddhist population around the world, thereby strengthening the country’s soft power.

India’s efforts so far

  • Buddhist tourist circuit: The Indian government has been actively investing in its Buddhist diplomacy efforts, with a focus on promoting tourism through the development of the “Buddhist tourist circuit”.
  • Personal Visits: PM Modi has made it a point to visit Buddhist sites during his Southeast and East Asian visits. 
  • Statements: Against the backdrop of the Russia-Ukraine crisis, Mr. Modi said, “India has not given ‘ Yuddha’ to the world but ‘Buddha’.” This resonates with his earlier statement of his telling the Russian President, Vladimir Putin, that ‘this is not the era of war’. 

Guiding Principle

  • Sanskriti Evam Sabhyata:The current government’s guiding principles for foreign policy, Panchamrit principles include “ Sanskriti Evam Sabhyata” which means cultural and civilizational links, which were highlighted during the Delhi summit.
  • Committed to Peace: Through such efforts, India hopes to reinforce its image as a responsible global power committed to peaceful cooperation and regional stability. 
  • Greater cooperation: By laying an emphasis on cultural and civilisational ties, India seeks to promote greater understanding and cooperation between nations and to demonstrate the unique role it can play in shaping the region’s future.
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