What are the main objectives of the Indian Regulatory Framework?

To ensure safety, efficacy, and quality of products, protect public health, and facilitate innovation.

True or False: 

The Indian Regulatory Framework allows for the approval of drugs without any clinical trials.

False. 

Clinical trials are essential for drug approval.

What role does the Central Drugs Standard Control Organization (CDSCO) play in India's regulatory framework?

The CDSCO regulates drug approval and ensures the safety and efficacy of drugs in India.

Riddle: 

I monitor drugs from start to finish, ensuring safety's not a glitch. What am I?

The Central Drugs Standard Control Organization (CDSCO)

Explain the purpose of pharmacovigilance in the context of the Indian regulatory framework.

Pharmacovigilance aims to monitor the safety of drugs post-approval to identify adverse effects and ensure public safety.

What is the primary function of the Food Safety and Standards Authority of India (FSSAI)?

To regulate and ensure the safety and quality of food products in India.

Riddle: 

I ensure your food is safe and sound, in my guidelines, good health is found. What am I?

Food Safety and Standards Authority of India (FSSAI)

True or False: 

The Drug Controller General of India (DCGI) is responsible for the approval of medical devices.

True. 

The DCGI oversees the approval process for both drugs and medical devices.

What does the term 'bioavailability' refer to in the context of drug regulation?

Bioavailability refers to the degree and rate at which an active ingredient or active moiety is absorbed and becomes available at the site of action.

Fill in the blank: 

The Indian regulatory framework emphasizes the importance of ___ in clinical research.

Informed consent

What is the role of the National Pharmaceutical Pricing Authority (NPPA)?

The NPPA regulates the prices of pharmaceutical products to ensure affordability and accessibility.

Riddle: 

I set the prices for medicines, keeping costs in line, ensuring access for all, making health divine. What am I?

National Pharmaceutical Pricing Authority (NPPA)

Discuss the importance of Good Manufacturing Practices (GMP) in the Indian regulatory framework.

GMP is crucial in India.

• Ensures product quality standards.

• Minimizes pharmaceutical production risks.

• Supports regulatory compliance in India.

What is the key purpose of the Clinical Trials Registry - India (CTRI)?

The CTRI aims to register clinical trials conducted in India to promote transparency and accountability in research.

The Indian Regulatory Framework is primarily designed to ensure ___ and ___ in various sectors.

Safety and compliance

A company is planning to restructure due to financial distress. 

Which regulatory body and law should it approach?

The Insolvency and Bankruptcy Board of India (IBBI) under the Insolvency and Bankruptcy Code, 2016.

If a Chartered Accountant advises on a merger, which ministry governs the Companies Act and must be consulted?

Ministry of Corporate Affairs.

A pharmaceutical firm plans to launch a new drug. 

Which approval process must it follow?

Clinical trials per Schedule Y, regulated by CDSCO under the Drugs and Cosmetics Act, 1940.

If a consumer files a writ petition for violation of fundamental rights, which courts can they approach?

The High Court under Article 226 or the Supreme Court under Article 32.

During the Union Budget, new taxation rules are announced. 

Which ministry is responsible, and who implements them?

Ministry of Finance; implemented by the Indian Revenue Service.