Why in news
- Central Drugs Standard Control Organisation (CDSCO) flagged a counterfeit batch of Abhayrab rabies vaccine in circulation, prompting multi-state enforcement actions.
What is the legal framework for drug quality control?
- Regulated under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
- The **Central Drugs Standard Control Organisation (CDSCO)**, headed by the Drugs Controller General of India (DCGI), is the national regulatory authority.
- State Licensing Authorities (SLAs) enforce manufacture, sale, and distribution standards, while central authorities handle approvals and import quality.
Classification of substandard drugs
- Not of Standard Quality (NSQ): Failing official pharmacopoeial specifications in active ingredients, dissolution, or stability.
- Spurious/Misbranded: Products manufactured under false labeling, imitating licensed brands, or lacking actual active ingredients.
Why it matters
- Failure in biological products such as post-exposure rabies vaccines presents direct lethal risks due to 100 percent case fatality rate of rabies upon onset.
- Highlights the necessity for track-and-trace QR code enforcement on top pharmaceutical brands to prevent counterfeit market penetration.
Key terms
Misbranded Drug
A drug labeled in a misleading manner or bearing packaging intended to imitate another manufacturer's licensed product.
Biological Product
A medical product derived from living organisms, including vaccines, blood products, and recombinant proteins.
Prelims facts
- CDSCO acts as the central regulator while State Licensing Authorities issue manufacturing and retail licenses under the Drugs and Cosmetics Act, 1940.
Mains discussion
- Examine the regulatory gaps in India's drug supply chain and evaluate measures needed to eliminate counterfeit medical products.
Source: Economic Times
Same topic · past papers
UPSC has asked this before
These previous-year questions sit on the same topic. Open one to practise the earlier ask.
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2022 · Q16 · GS III · 15 marks
What is the basic principle behind vaccine development? How do vaccines work? What approaches were adopted by the Indian vaccine manufacturers to produce COVID-19 vaccines ? -
2022 · Q39 · General Studies · 2 marks
In the context of vaccines manufactured to prevent COVID-19 pandemic, consider the following statements: 1. The Serum Institute of India produced COVID-19 vaccine named Covishield using mRNA platform. 2. Sputnik V vaccine is manufactured using vector based platform. 3. COVAXIN is an inactivated pathogen based vaccine. Which of the statements given above are correct? -
2020 · Q45 · General Studies · 2 marks
What is the importance of using Pneumococcal Conjugate Vaccines in India? 1. These vaccines are effective against pneumonia as well as meningitis and sepsis. 2. Dependence on antibiotics that are not effective against drug resistant bacteria can be reduced. 3. These vaccines have no side effects and cause no allergic reactions. Select the correct answer using the code given below: -
2026 · Q29 · General Studies · 2 marks
Which of the following is/are the most significant implication(s) of obtaining Oeko-Tex certification for Eri Silk in the global textile industry? 1. It allows Indian exporters to compete in high-end markets that prioritise chemical-free products. 2. It confirms that Eri Silk meets international safety, environmental, and quality standards, enabling its entry into premium eco-conscious markets. Select the answer using the code given below: -
2026 · Q51 · General Studies · 2 marks
Mr. X, a senior officer, was overseeing a critical vaccination programme during a pandemic. He found that a private service provider responsible for vaccine distribution was compromising on quality to make profits. Despite immense pressure to manage the issue due to vested interests, he raised his voice based on the principles of public administration which he learnt during various training programmes attended across his career. He reported the issue to the appropriate vigilance authority and halted the contract to ensure citizen welfare. Which one among the following principles of public administration was most strongly demonstrated by Mr. X's actions?