The lack of a drug recall law in India (GS Paper 2, Health)
Why in news?
- Recently, Abbot, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market.
- While such recalls take place regularly in the U.S., India have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.
Is there a drug recall law in India?
- One of the reasons for this difference in behaviour in India and the U.S. is because the law in the latter requires pharmaceutical companies to recall from the market those batches of drugs that have failed to meet quality parameters.
- India, on the other hand, has been mulling the creation of a mandatory recall law for substandard drugs since 1976, and yet no law exists that mandates such medicine be removed from the market to this day.
- In 1976, the Drugs Consultative Committee, which consists of all the state drug controllers along with senior bureaucrats from the Ministry of Health and the national drug regulator, the Central Drugs Standard Control Organisation (CDSCO), discussed the issue of drug recalls.
- The minutes of this meeting record a discussion on how drugs ordered to be recalled by a state drug controller in one State were found to be on sale in another State.
- Since then the issue has come up repeatedly in regulatory meetings in 1989, 1996, 1998, 2004, 2007, 2011, 2016, 2018 and 2019 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 a combination of factors including apathy, lack of expertise and a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
- India’s highly fragmented regulatory structure, with each State having its own drug regulator. But despite the fragmentation, drugs manufactured in one State can seamlessly cross borders to be sold in all States around the country.
- To create an effective recall mechanism, the responsibility of recalling drugs has to be centralised, with one authority wielding the legal power to hold companies liable for failures to recall drugs from across the country. However, both the pharmaceutical industry and state drug regulators have resisted greater centralisation of regulatory powers.
- India’s drug regulators are aware of the fact that a mandatory drug recall system, which necessarily has to be centred on a system of wide publicity, will bring to public attention 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.
EC to pilot facial recognition at polling booths for ease of voting
(GS Paper 2, Governance)
Why in news?
- The Election Commission of India has worked out a way to ensure a smooth polling process for voters in Karnataka.
Details:
- In Bengaluru, polling booths will be equipped with facial recognition technology after concerns were raised by activists about privacy.
- The first-of-its-kind system will be piloted in one polling station; Room no. 2, Government Ramnarayan Chellaram College on Palace Road, near the office of the Karnataka Chief Electoral Officer.
How will it work?
- To be a part of the system, voters will be required to use EC’s Chunavana mobile application following which they will enter their Elector’s Photo Identity Card (EPIC) number, and mobile number and an OTP will be sent to their registered numbers. After this, voters will have to upload a selfie on the app.
- After the registration process, voters will undergo a facial recognition scanner once they reach the polling booth.
- If the photo matches that in the EC’s database, they would no longer need to provide documents and will be cleared to cast their votes.
- With this system, cases of bogus voting and electoral malpractices while reducing long queues.
Advantages:
- It will cut down the queue/waiting time for voting.
- Less manpower is needed. For instance, instead of four polling officers at a booth, only three can be deployed because there’s no need for further checks/verification due to this face recognition technology.
- The novel idea was brought about after students of the Department of Computing Technologies from SRM University won a 30-hour offline hackathon to tackle voting apathy.
- Apart from escaping long waiting lines, the Chunavana mobile application will also tell voters about the available parking spaces near the polling booth. They can also check the queue status on the app in real-time.
What are the regulations to curtail misleading food ads?
(GS Paper 2, Governance)
Why in news?
- Recently, the Advertisement Monitoring Committee at the Food Safety and Standards Authority of India (FSSAI) flagged 32 fresh cases of food business operators (FBOs) making misleading claims and advertisements.
- As per the regulator, the count of such offences has shot up to 170 in the last six months.
What are the regulations?
- There are varied regulations to combat misleading advertisements and claims, some are broad, while others are product specific.
- For example, FSSAI uses the Food Safety and Standards (Advertising & Claims) Regulations, 2018 which specifically deals with food (and related products) while the Central Consumer Protection Authority (CCPA)’s regulations cover goods, products and services.
- Further, the Programme and Advertising Codes prescribed under the Cable Television Network Rules, 1994 stipulate that advertisements must not imply that the products have “some special or miraculous or supernatural property or quality, which is difficult of being proved.”
- The FSSAI seeks that the advertisements and claims be “truthful, unambiguous, meaningful, not misleading and help consumers to comprehend the information provided”.
- The claims must be scientifically substantiated by validated methods of characterising or quantifying the ingredient or substance that is the basis for the claim.
- Product claims suggesting a prevention, alleviation, treatment or cure of a disease, disorder or particular psychological condition is prohibited unless specifically permitted under the regulations of the FSS Act, 2006.
When can a product be referred to as ‘natural’ and ‘fresh’?
- A food product can be referred to as ‘natural’ if it is a single food derived from a recognised natural source and has nothing added to it. It should only have been processed to render it suitable for human consumption. The packaging too must be done sans chemicals and preservatives.
- Composite foods, which are essentially a mixture of plant and processed constituents, cannot call themselves ‘natural’, instead, they can say ‘made from natural ingredients’.
- ‘Fresh’ can be used for products which are not processed in any manner other than washing, peeling, chilling, trimming, cutting or irradiation by ionising radiation not exceeding 1 kGy or any other processing such that it remains safe for consumption with the basic characteristics unaltered.
- Those with additives (to increase shelf life) may instead use ‘freshly frozen’, ‘fresh frozen’, or ‘frozen from fresh’ to contextualise that it was quickly frozen while 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 may either be about the specific contents of a product or comparisons with some other foodstuff.
- Claims of equivalence such as “contains the same of (nutrient) as a (food)” or “as much (nutrient) as a (food)” may be used in the labelling provided that it gives the equivalent nutritional value as the reference food.
- 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.
