Drug Recall Law in India
Tags: Syllabus/GS2/Government Policies and Interventions for development in various sectors, Health
• Recent failures of Indian-made medications abroad (such as the Gambia incident) have drawn attention to the lack of a drug recall law in the Indian pharmaceutical industry.
What is a Drug Recall?
• The defective products related to quality are Not of Standard Quality, Adulterated, and Spurious pharmaceuticals.
Status of Drug Recall Law in India
• Since 1976, India has been contemplating the creation of a law mandating the removal of substandard pharmaceuticals from the market, but no such law currently exists.
• In 1976, the Drugs Consultative Committee (DCC) and various state regulators discussed the issue of drug recalls, but none of these discussions resulted in amendments to the Drugs & Cosmetics Act to establish a mandatory recall mechanism.
• In 2012, the Central Drugs Standard Control Organisation (CDSCO) drafted a set of recall guidelines, but the national regulator lacks the authority to transform the guidelines into a legally binding statute.
• Recalls resurfaced in 2016 during meetings of the DCC and the Drugs Technical Advisory Board (DTAB). There was no change to the terrain. The same topic was discussed at DCC meetings in 2018 and 2019, but 46 years later, India still lacks a recall law.
Reasons for not having the Law?
• Complex Drug Regulatory Issues: The Drug Regulation Section of the Union health ministry is simply incapable of addressing complex drug regulatory issues due to a combination of factors, including apathy, lack of expertise in the field, and a greater interest in facilitating the expansion of the pharmaceutical industry.
• There is no centralized regulatory authority; India’s regulatory structure is highly fragmented, with each state having its own drug regulator. Both the pharmaceutical industry and state drug regulators have opposed increased regulatory centralisation.
• Fear of Public Scrutiny: Each month, dozens of pharmaceuticals fail random government laboratory testing. Ideally, these medications will be recalled in a transparent manner, and the public will be informed of the failures. If this were to actually occur in India, however, the general public would be inundated with alerts almost daily, thereby increasing the pressure on drug regulators to implement extensive reforms.
Present Laws Regulating the Drugs and Pharmaceutical Sector in India
- Central Drugs Standard Control Organisation: This organization is India’s National Regulatory Authority (NRA).
- The Drugs and Cosmetics Act of 1940 and Rules of 1945 have assigned various responsibilities for the regulation of drugs and cosmetics to central and state regulators. It envisions uniform implementation of the provisions of the Act and Rules promulgated thereunder to ensure the safety, rights, and well-being of patients through the regulation of pharmaceuticals and cosmetics.
- The CDSCO and state regulators are jointly responsible for the issuance of licenses for certain specialized categories of essential drugs, such as blood and blood products, intravenous fluids, vaccines, and serums.
- The Drugs and Cosmetics Act of 1940 regulates the import, production, distribution, and sale of pharmaceuticals in India.
- The Pharmacy Act of 1948 is intended to regulate the pharmacy profession in India.
- The Drugs and Magic Remedies (Objectible Advertisement) Act of 1954: This law regulates the advertising of drugs and prohibits the advertising of purportedly magical remedies.
- The Narcotic Drugs and Psychotropic Substances Act of 1985: This act regulates and controls operations involving Narcotic Drugs and Psychotropic Substances.
- National Pharmaceutical Pricing Authority: An organization of the Government of India established, among other things, to fix/revise the prices of controlled bulk drugs and formulations and to enforce the prices and availability of medicines in the country, in accordance with the Drugs (Prices Control) Order of 1995.
- The organization is also tasked with recovering amounts overcharged to consumers by manufacturers of controlled substances. In addition, it monitors the prices of decontrolled pharmaceuticals to maintain reasonable levels.
• To create an effective recall mechanism, the responsibility of recalling drugs must be centralized, with a single authority that has the legal authority to hold companies liable for failures to recall drugs from across the country, as well as the ability to search for and confiscate batches of defective medicine.
• If India is a singular drug market, it should have a single regulatory body. If not, the incompetence of a regulator in a single state can have negative effects on patients in other states, whose citizens lack the influence or electoral power to hold that regulator accountable.
Misleading Food Advertisements
Tags: Syllabus: GS2/ Government Policies & Interventions
• The Food Safety and Standards Authority of India (FSSAI) has recently identified 32 new instances of deceptive advertising and claims made by Food Business Operators (FBOs).
More about the news
- In contravention of the Food Safety and Standards:
- It was determined that the advertisements in question violated the 2018 Food Safety and Standards (Advertisements & Claims) Regulations.
- Who are these violators?
- FSSAI affirmed that they examined products in diverse categories, such as health supplements, organic products, fast-moving consumer goods (FMCG) products, and staples, with each category endorsing specific health and product claims.
- Manufacturers and/or distributors of nutraceutical products, refined oils, pulses, flours, millet products, and ghee are among the alleged infringers.
- Entity-specific regulations:
- FSSAI employs the Food Safety and Standards (Advertisements & Claims) Regulations, 2018, which deal specifically with food (and related products).
- The regulations of the Central Consumer Protection Authority (CCPA) apply to goods, products, and services.
- Broadcasting regulations:
- According to the Programme and Advertising Codes outlined in the Cable Television Network Rules of 1994, advertisements may not imply that a product possesses “some special or miraculous or supernatural property or quality that is difficult to prove.”
- Consumer Protection Act, 2019:
- The Consumer Protection Act was enacted to address violations of consumer rights, discriminatory business practices, deceptive advertising, and all other circumstances that are detrimental to consumer rights.
- Claims suggesting a product’s suitability for the prevention, alleviation, treatment, or cure of a disease, disorder, or specific psychological condition are prohibited unless expressly permitted by the FSS Act of 2006 regulations.
- Section 53 of the Food Safety and Standards Act of 2006 criminalizes making deceptive claims or advertisements.
Concerns & challenges
- Rising offences:
- According to the regulator, the cumulative number of such violations has risen to 170 in the last six months.
- The regulator urged FBOs to “cease making any unscientific and/or exaggerated claims and advertisements to promote their product sales in order to avoid enforcement actions and in the interest of the consumer in general.”
- The majority of misleading claims were based on insufficient evidence for a product’s nutrition, benefits, and ingredient combination. A significant amount of claim data must be based on technical data.
- If you claim that your product contains vitamin D, for instance, you must provide evidence to support your claim.
- Need of adequate clinical data:
- If the claim relates to the composition of the product, stating that a product with all of its components accomplishes a particular outcome, companies must provide clinical data regarding the outcomes of the control group, the administered group, and the observed period of the claimed outcomes.
- What does the regulator expect?
- FSSAI desires that advertisements and claims be “truthful, unambiguous, meaningful, not misleading, and assist consumers in comprehending the provided information.”
- Claims must be supported by validated methodologies for characterizing or quantifying the ingredient or substance upon which the claim is based.
- It is of the utmost importance that consumers can differentiate between regular posts and promotional content.
- Any endorsement must reflect the genuine, reasonably current opinion of the individual, group, or organization making such a representation and must be based on adequate information or experience with the identified goods, product, or service.
- An ideal advertisement is suggestive and not passively imposing; it should educate the public; and finally, “it must be true!”
Thalassemia Bal Sewa Yojana
Tags: Syllabus: GS 2/Health
• In New Delhi, the Minister of State for Health introduced the third phase of the Health Ministry’s Thalassemia Bal Sewa Yojana.
About Thalassemia Bal Sewa Yojana
- The Union Health Ministry has been implementing the Thalassemia Bal Sewa Yojana under the National Health Mission (NHM) since 2017; the program’s second phase was concluded in March 2023.
- The third phase of the program will continue to provide financial support for a package cost of 10 lakhs per Hematopoietic Stem Cell Transplant (HSCT), transmitted directly from CIL to institutions performing HSCT.World Thalassemia Day is being supported by Coal India Limited as part of their Corporate Social Responsibility initiative.It is a one-time cure opportunity for Thalassemia patients from disadvantaged backgrounds who have a matched sibling donor but lack the financial resources to cover the cost of the procedure.
- The program is an excellent example of a successful CSR initiative that is making a real difference in the lives of thalassemia patients and their families.
- The third phase will continue to bring hope and relief to thalassemia patients and their families and contribute towards building a healthier and more equitable society.
- The program will benefit underprivileged thalassemia patients and those with aplastic anemia, which is an irreversible condition that can be life-threatening without treatment
Types of Thalassemia
Saint Samarth Ramdas
Tags: Syllabus/GS1/Famous Personalities
• Jaggi Vasudev’s claim that Saint Samarth Ramdas was Chhatrapati Shivaji Maharaj’s guru recently sparked a controversy.
Who was Samarth Ramdas?
• Samarth Ramdas (1608-1681), also referred to as Sant Ramdas or Ramdas Swami, was a Hindu saint, philosopher, poet, author, and spiritual instructor.
• His paean to Lord Hanuman, Maruti Stotra, is still recited by school children and wrestlers across Maharashtra.
• He constructed a Rama and Maruti (Hanuman) temple and founded a math or monastery that still exists today.
• The community of his adherents quickly grew and assumed the characteristics of a distinct sect, the Ramdasi sect, with its own sacred texts and modes of worship.
- Ramdas was an advocate of Bhakti Yoga or the devotional path. According to him, complete devotion to Rama leads to spiritual development.
- He expressed his reverence for warriors and emphasized their importance in protecting society. He believed that saints should not recede from society but rather actively participate in social and moral transformation.
- He promoted women’s participation in religious activity and provided them with positions of authority.
• Throughout the years, Ramdas has influenced Hindu nationalist intellectuals. Lokmanya Tilak, the founder of the RSS, KB Hedgewar, and VD Savarkar all claimed to have been influenced by the 17th century sage.
Space Science and Technology AwaReness Training (START)
Tags: Syllabus: GS3/ Science & Technology, Space
• The Indian Space Research Organisation (ISRO) has announced a new Space Science and Technology Awareness Training (START) introductory-level online training program.
About the Programme
- Objective: To provide training in Space Science and Technology at the introductory level in order to build human capacity for future Space Science and research.
- The curriculum will include Astronomy and Astrophysics, Heliophysics and Sun-Earth Interaction, Instrumentation, and Aeronomy.
- Participants: START is intended for graduate and senior-level Physical Sciences and Technology undergraduates.
- Applied by means of: Jigyasa portal
• ISRO was formerly known as the Indian National Committee for Space Research (INCOSPAR), which was established in 1962 by the Government of India per the vision of Dr. VikramA Sarabhai.ISRO was established on August 15, 1969, replacing INCOSPAR with an expanded mission to utilize space technology. In 1972, DOS was established and ISRO was incorporated under DOS.ISRO’s primary mission is the development and application of space technology for diverse national requirements.
• Headquarters: Bengaluru
Tags: Syllabus: GS 3/Infrastructure
• The Ministry of Housing and Urban Affairs (MoHUA) and the Japan International Cooperation Agency (JICA) have inked a memorandum of understanding (MoU) for the Project-SMART.
• Station Area Development along Mumbai-Ahmedabad High-Speed Rail (SMART) is an initiative to modernize India’s railway infrastructure, with the potential to transform the regions surrounding high-speed rail stations into thriving economic hubs.
• The MoU was signed for four of the twelve high-speed stations on the route: Sabarmati, Surat in Gujarat, Virar and Thane in Maharashtra. Green field projects include Surat, Virar, and o Thane, while brown field projects include Sabarmati.
• The SMART project intends to develop the areas encircling MAHSR stations to improve the accessibility and convenience of commuters and other stakeholders, as well as to encourage economic activity in the vicinity of station areas.
• This initiative to modernize India’s railway infrastructure has the potential to transform the areas surrounding high-speed rail stations into thriving economic hubs.
•It will also strengthen the institutional capacity of state governments, municipal corporations, and urban development authorities to plan, develop, and administer the MAHSR stations’ surrounding areas.
Respiratory Syncytial Virus (RSV)
Tags: Syllabus: GS3/ Science & Technology
• In May of 2023, the Food and Drug Administration (FDA) of the United States authorized the Arexvy vaccine against respiratory syncytial virus (RSV).
• This is the first RSV vaccine to be approved anywhere in the world.
• Arexvy will reduce respiratory tract disease in individuals aged 60 and older.
• The company GSK manufactures the vaccine.
Respiratory Syncytial Virus (RSV)
• RSV causes lung and respiratory tract infections.
• Symptoms: RSV typically causes moderate cold-like symptoms, such as a runny or congested nose, dry cough, low-grade fever, sore throat, sneezing, and headache.
RSV infection can cause bronchiolitis (inflammation of the narrow airways in the lung) and pneumonia (infection of the lungs) in severe cases.
• Mortality: Diseases of the lower respiratory tract caused by the RSV virus result in approximately 60,000-1,200,000 hospitalizations and 6,000-10,000 fatalities among adults aged 65 and older.
• Vulnerable Groups: Infants and older adults with comorbidities are at high risk for RSV infection.
• Treatment: Most children and adults recover within one to two weeks, although hospitalization may be necessary for some.
• Protein F: Scientists have determined that the introduction of protein F, a fibronectin-binding protein that has not yet fused with a human cell, elicited neutralizing antibodies against the virus.
Tags: Syllabus: GS3/ Defence
• An Indian Air Force (IAF) MiG-21 fighter aircraft crashed near Suratgarh, Rajasthan. Unknown is the precise cause of the accident.
Status of the MIG-21 Jets in the IAF
• The Indian Air Force (IAF) currently operates six MiG-21s among its six other fighter aircraft.
• The Mikoyan-Gurevich MiG-21 is a single-engine, single-seat, multirole fighter/ground attack aircraft designed by the Mikoyan-Gurevich Design Bureau in the Soviet Union/Russia.India first introduced them in 1963. Since then, India has acquired over 700 MiG-21 aircraft of various variants, including the Type-77, Type-96, and the BIS. The most recent is the MiG-21 Bison.
• Function: The aircraft had proven their worth in several wars waged by India against Pakistan (1965, 1971, and the 1999 Kargil conflict).
• Incidents: Nearly 500 MiG-21s have crashed in the last 60 years, murdering over 170 pilots, according to available government data.
• The causes of the accidents have been diverse, including technical defects, human error, bird strikes, and spatial disorientation of pilots under certain conditions.
Phasing out of MiG
• The No. 51 squadron was numbered in September 2022.
The elimination of the three MiG-21 Bison battalions is scheduled for December 2025.
• Squadrons of the indigenous Light Combat Aircraft Tejas will supplant them.
Tags: Syllabus: GS1/ Places in News
• Credit Suisse, a Swiss bank, has announced that it will purchase Ecuadorian bonds worth $1.6 billion as part of a debt-for-nature trade at a cost of $644 million.
- In exchange, the Ecuadorian government will spend approximately $18 million annually for 20 years on conservation efforts in the Galapagos Islands.
• The Galapagos Islands are an archipelago of volcanic islands belonging to the country of ‘Ecuador’ in South America.
The archipelago is situated in the eastern Pacific near the Equator. The chain of islands is located in both the northern and southern hemispheres because it straddles the equator.
• Geology: The archipelago is situated on the Nazca Plate, which is migrating east-southeast and submerging beneath the South American Plate. The Galápagos Islands have experienced continuous volcanism for at least 20 million years.
• Ecology: The Galapagos Islands are renowned for their abundance of endemic species, which Charles Darwin studied in the 1830s and which inspired his theory of evolution by natural selection. The Galapagos Islands are named for the gigantic tortoises that inhabit them.