Questionnaire

1. What defines a generic medicine, and how does it differ from branded drugs? 
2. Explain the regulatory mechanisms in place for Generic Medicines within the Indian pharmaceutical industry. 
3. What recent actions has the government taken regarding the revision of GMP (Good Manufacturing Practices) for pharmaceuticals, and what impact does this hold? 
4. What are some of the major challenges faced by Generic Medicines in India?

Context: Recently, the Union government directed pharmaceutical companies to implement the revised Good Manufacturing Practices (GMP).

What defines a generic medicine, and how does it differ from branded drugs? 

• A generic drug is a pharmaceutical product that contains the same active ingredient(s), in the same dosage form and strength, and has the same therapeutic effect as a reference product but is marketed under a different name.
• Generic Medicines vs. branded drugs:

What are the advantages or benefits associated with the usage of Generic Medicines?

• Cost-effectiveness: Generic Medicines are generally more affordable than brand-name drugs, making healthcare more accessible and reducing expenses for patients and healthcare systems.
• Increased Access: Availability of Generic Medicines widens access to essential medications, especially for poor populations.
• Equivalent Quality and Efficacy: Generic Medicines undergo stringent regulatory standards to ensure they are bioequivalent to brand-name drugs, providing comparable quality and efficacy.
• Competition and Innovation: Increased competition among generic drug manufacturers can drive innovation and reduce prices for consumers.

Explain the regulatory mechanisms in place for Generic Medicines within the Indian pharmaceutical industry? 

• The regulatory process for Generic Medicines in India is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945. 
• The Central Drugs Standard Control Organization (CDSCO): The CDSCO is the national regulatory authority for drugs and cosmetics in India. The CDSCO is responsible for reviewing and approving generic drug applications, conducting inspections of manufacturing facilities, etc. 
• The National Pharmaceutical Pricing Authority (NPPA): The NPPA is responsible for regulating the prices of drugs in India.

What recent actions has the government taken regarding the revision of GMP (Good Manufacturing Practices) for pharmaceuticals, and what impact does this hold? 

• The Government of India directed pharmaceutical companies to implement the revised Good Manufacturing Practices (GMP). 
• Aim: The revised GMP aims to ensure that the quality and safety of drugs produced in India are consistent with global norms. 
• The revised GMP guidelines focus on:
  • Quality control measures
  • Proper documentation
  • IT backing
  • Pharmaceutical quality system
  • Quality risk management
  • Product quality review
  • Validation of equipment.
• Deadlines: The government has announced different deadlines for different categories of companies to implement the revised GMP:  
  • Companies with a turnover of Rs 250 crore and more will have to implement the revised GMP within six months. 
  • Medium and small-scale enterprises with a turnover of less than Rs 250 crore will have to implement it within a year.
• Need for the revised GMP:
  • Safety Concerns: Incidents of contamination in Indian-manufactured drugs causing fatalities raise significant safety concerns.
  • Widespread Non-compliance: Most drug manufacturing units (8,500 out of 10,500) don’t meet global standards, indicating a lack of adherence to quality practices.
  • Critical Deficiencies Found: Inspections reveal serious gaps like untested raw materials, inadequate quality reviews, infrastructure issues, and poor documentation.
  • Global Reputation Impact: These incidents damage India’s pharmaceutical industry reputation globally.
• Significance of the move: 
  • The revised GMP will bring the Indian industry on par with global standards. 
  • This will improve the quality of medicines available in India as well as sold in global markets.

What are some of the major challenges for the adoption of Generic Medicines in India?

• Perception and Awareness: Lack of understanding or misconceptions about Generic Medicines among patients and healthcare professionals can hinder their acceptance and usage.
• Brand Loyalty: Strong loyalty to specific brand-name drugs may deter patients from switching to cost-effective generic alternatives.
• Trust and Misinformation: Instances of substandard or counterfeit Generic Medicines and misinformation can erode trust in their quality and effectiveness.
• Prescription Practices: Healthcare professionals’ prescribing patterns and potential incentives from pharmaceutical companies may influence the preference for brand-name drugs over generics.
• Regulatory Compliance: Ensuring consistent adherence to quality standards across all generic drug manufacturers poses a challenge, requiring stringent monitoring and enforcement.
• Price Differentials: Despite being more affordable, substantial price differences between some generic and brand-name drugs can still pose financial barriers for certain patients.
• Intellectual Property Concerns: Patent-related issues and complex litigation processes can delay the entry of generic versions.

What are the steps taken for the promotion of Generic Medicines in India?

• Establishment of PMBJKs: Over 9,500 dedicated outlets called Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) provide quality generic medicines at significantly reduced prices (50-90% lower than branded medicines).
• Mobile Application ‘Janaushadhi Sugam’: A mobile app offers information on Kendra locations, and helps locate and compare generic vs. branded medicine prices.
• Regulatory Directives: Government regulations mandate physicians to prescribe drugs using generic names, and Central Government hospitals and CGHS doctors are directed to prescribe generic medicines only.
• NHM Free Drug Initiative: The National Health Mission supports the provision of essential Generic Medicines free of cost in public health facilities.
• Quality Assurance: PMBJKs sell only quality generic medicines procured from WHO-GMP-certified suppliers. Every batch undergoes testing at NABL-accredited laboratories.
• Regulatory Measures by Health Ministry and CDSCO: Various amendments in the Drugs and Cosmetics Rules ensure efficacy and proper naming in drug applications. National List of Essential Medicines (NLEM) inclusion helps in pricing control by NPPA under DPCO, 2013.
• Bioequivalence Studies: Amendments in the Drugs and Cosmetics Rules require applicants to submit bioequivalence study results for specific drugs to ensure their effectiveness.
• Proper Naming and Branding: Amendments mandate applications for drug licenses to use proper/generic names, and if marketed under a brand name, applicants must ensure uniqueness and clarity to avoid confusion.
• Pricing Regulation: NPPA fixes ceiling prices for scheduled medicines under DPCO, 2013, with the inclusion of new drugs and provisions for public interest-based pricing in extraordinary circumstances.

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