DRUG REGULATION CHALLENGES IN INDIA
This editorial is based on a piece called Safety first that appeared in The Hindu on June 20, 2023. It discusses the dangers of Indian medicines and their repercussions.
India is one of the world’s top producers and exporters of pharmaceutical goods, meeting around 20% of the demand for generic medications worldwide. India is the third-largest biotechnology destination in Asia Pacific and one of the top 12 biotechnology locations worldwide. India’s biotechnology sector reached USD 80.12 billion in 2022, up 14% from the year before. Millions of people around the world, particularly in poor nations, now have better health outcomes and easier access to affordable medications because to India’s pharmaceutical industry. However, the Indian pharmaceutical business has also been accused of creating subpar, tainted, or dangerous medications that have led to ill effects and patient deaths in a number of nations, including Sri Lanka, the Gambia, Uzbekistan, the United States, etc. The quality and safety of pharmaceutical products made in India, as well as the function and efficiency of the Indian drug regulator in maintaining adherence to standards and guidelines, have all been seriously questioned as a result of these instances.
What are the possible reasons for inadequate drug safety standards?
inadequate enforcement and regulation:
The Drugs and Cosmetics Act, 1940, which governs drug regulation in India, is out-of-date and unable to address the complexities and difficulties of the contemporary pharmaceutical sector. Many areas of guaranteeing the quality and safety of drugs—such as clinical trials, bioequivalence studies, proper manufacturing practises, etc.—are not covered by the Act. Furthermore, the Act’s enforcement is ineffective and disjointed because it involves numerous federal and state agencies with overlapping mandates.
Insufficient resources
To effectively inspect, test, monitor, and supervise drug production facilities and products, there is a lack of labour, infrastructure, funding, and technology.
Lack of Accountability and Transparency:
The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulatory body, does not provide the general public or the media with a lot of information regarding its operations, procedures, results, etc. There is no system in place to assess its effectiveness or influence on the reduction of fake or inferior pharmaceuticals. Additionally, there is no system to guarantee that the regulator is impartial, independent, and free from outside pressures or influences from the government or the industry. Allegations of corruption, cooperation, and conflicts of interest between some CDSCO officials and some pharmaceutical corporations have been made.
Lack of Compliance and Awareness Among Pharmaceutical Companies:
Some pharmaceutical businesses in India do not follow the guidelines and standards set forth for the production, testing, labelling, packing, storage, and distribution of medicines. To reduce costs or boost profits, some pharmaceutical businesses also turn to unethical or criminal practises such using inferior or fake raw materials, adulterating or diluting pharmaceuticals, falsifying or manipulating data or documentation, etc. Additionally, they are not aware of or knowledgeable about the rules and regulations that apply to other markets or nations. They could not have sufficient quality control methods or procedures to spot or stop mistakes or flaws in their goods.
What Effects Do Ineffective Regulations Have?
Health Risk to the Public:
Poor quality and safety of Indian pharmaceutical items can seriously impact public health by giving patients who ingest them side effects like infections, allergies, organ damage, poisoning, etc. Patients with chronic or fatal diseases including HIV/AIDS, tuberculosis, malaria, cancer, etc. may experience treatment failure, drug resistance, complications, or even death as a result of this.
Loss of Public Confidence:
Patients and healthcare professionals lose faith and confidence in Indian pharmaceutical items as a result of ineffective regulation.
Economic Growth Negative Effects
By harming the reputation and competitiveness of India’s pharmaceutical industry in the international market, subpar quality and safety of Indian pharmaceutical products might have a negative impact on economic growth. Due to restrictions, recalls, or rejections of their products by foreign regulators or customers, this may result in market share, revenue, and profit losses for Indian pharmaceutical businesses. Consequently, this will result in the Indian pharmaceutical industry losing out on investments, employment prospects, and foreign exchange profits. They may also subject India’s pharmaceutical business to liabilities or penalties for breaking international laws or standards.
International relations harm
Indian pharmaceutical products’ subpar quality and safety might impact foreign relations by undermining India’s reputation as a trustworthy and responsible partner in global health endeavours. This could lead to diplomatic disputes or confrontations between India and other nations who are impacted by poor quality or dangerous Indian medications.
Damage to global cooperation
They may prevent India from working cooperatively or collaboratively with other nations or organisations to solve widespread health issues like pandemics, epidemics, etc.
Major Organisations in India That Regulate Drugs and Pharmaceuticals:
Health and Family Welfare Ministry
Ministry of Fertilisers and Chemicals
Department of Commerce
Science and Technology Ministry
Environment Ministry
Department of Pharmaceuticals Patent Office Indian Council of Medical Research (ICMR) Directorate General of Health Services (DGHS)
DBT, the Department of Biotechnology
Environmental approval for manufacture is required by the Central Drugs Standard Control Organisation (CDSCO), which is led by the Indian Drug Controller General.
Advisory Committees + Statutory Committees + DCGI (I)
NPPA, the National Pharmaceutical Pricing Authority
2013 Drugs (Prices Control) Order
General Patent Control Officer
Scientific and Industrial Research Council (CSIR)
Laboratories The Drug Enforcement Administration’s (DEA) Drug
Indian controller general, DCGI (I) +
Advisory committees plus statutory committees
What should the next step be?
Modifying the 1940 Drugs and Cosmetics Act:
To address all facets and issues facing the pharmaceutical industry, the government should update the legal framework for drug regulation. It should also establish distinct and standardised criteria and norms for various medication categories and markets.
Rationalising and Simplifying Drug Regulatory Structure and Activities:
The government should establish a single, central agency with sufficient jurisdiction, funds, knowledge, and autonomy to oversee the whole pharmaceutical industry and guarantee the efficient application and observance of drug laws and standards.
Promoting a Quality and Safety Culture in the Pharmaceutical Industry:
The government should encourage the industry to implement voluntary self-regulation and quality certification programmes by offering incentives, recognition, assistance, and guidance for meeting standards and norms and providing high-quality medications.
The Drishti Mains issue
Examine the reasons and effects of Indian pharmaceutical products’ subpar quality and safety on the international market. Give some recommendations for how to strengthen India’s standing as the pharmacy of the global south while also raising the quality and safety of its pharmaceutical products.
Questions from the previous year’s UPSC Civil Services Exam (PYQs)
Prelims:
Which of the following describes why multi-drug resistance in microbial pathogens occurs in India? (2019)
- Some people have a genetic susceptibility
- using the wrong dosages of antibiotics to treat illnesses
- using antibiotics when raising livestock
- some people’s multiple chronic conditions
Using the code provided below, choose the right response.
(a) 1 and 2
(b) Only 2 and 3
(c) 1, 3 and 4
(d) 2, 3 and 4
Ans: (b)
Exp:
The ability of a microorganism (such as bacteria, viruses, and some parasites) to prevent an antimicrobial (such as an antibiotic, an antiviral, and an antimalarial) from operating against it is known as antimicrobial resistance (AMR). Standard treatments stop working as a result, infections linger, and they could spread to other people. A person is more likely to develop a specific disease based on their genetic make-up if they have a genetic predisposition (also known as genetic susceptibility). Specific genetic differences, which are frequently inherited from one’s parents, cause a hereditary predisposition. It is not directly connected to antibiotic resistance. 1 is therefore incorrect. AMR develops gradually and naturally. Antibiotics are frequently administered without medical supervision and are frequently overused and mistreated in both humans and animals. Examples of misuse include giving them to people who have viral infections like the flu or the common cold, giving them to animals as growth boosters, or using them to shield healthy animals from sickness. So, answers 2 and 3 are accurate. A person who has two or more chronic diseases concurrently is said to have multiple chronic diseases. A person who has both heart disease and depression and rheumatoid arthritis, for instance, is said to have several chronic conditions. Therefore, it is not necessary for a person with many chronic diseases to also have antimicrobial resistance, as some chronic diseases do not necessitate the administration of antibiotics. 4 is therefore incorrect. Therefore, the right response is option (b).