Revised Manufacturing Rules For Drug Firms: What Changes, And Why

Relevance: GS 3 - Changes in industrial policy and their effects on industrial growth. GS 2 -Government policies and interventions for development in various sectors and issues arising out of their design and implementation;

(Source: The Hindu, 08/07/23)

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Why in the news?

• Recently, the Jan Vishwas Bill was passed by both houses of Parliament with the aim to improve the ease of doing business in the pharmaceutical sector.
• The bill seeks to amend two provisions of the law governing the manufacture, storage, and sale of medicines in India.It will amend 183 provisions across 42 laws to do away with imprisonment or fines for certain offenses.

What was the need for improved standards?

• The Jan Vishwas Bill proposes two important changes to the Drugs and Cosmetics Act, 1940.
• The first change involves replacing imprisonment with fines for companies repeatedly using government analysis or test reports to promote their products. The second allows for the "compounding" of offences under specific sections of the existing law.
• Rationalization of standards: The implementation of the new norms will bring the Indian Pharmaceutical industry on par with global standards.
• The improved standards will ensure that pharmaceutical companies follow standard processes, and quality control measures, and do not cut corners, improving the quality of medicines available in India as well as sold in the global market.
• Recent contamination incidents: A series of incidents has emerged involving alleged contamination in syrups, eye drops, and eye ointments manufactured in India which have been linked to significant fatalities, including 70 children in the Gambia, 18 children in Uzbekistan, three individuals in the United States, and six deaths in Cameroon.
• Deficiencies: Government inspection of 162 manufacturing units identified deficiencies:
  • unchecked incoming raw materials,
  • lacking product quality reviews,
  • inadequate quality issue investigation,
  • cross-contamination risk,
  • flawed manufacturing/testing areas,
  • professional shortages, and inadequate documentation.
• Promotion of Good Manufacturing Practices(GMP): Out of the current 10,500 drug manufacturing units in the country, only 2,000 are WHO-GMP certified and meet global standards. After a series of incidents, a Chitan Shivir proposed implementing revised good manufacturing practices (GMP) from the 2018 draft schedule M of drugs and cosmetics rules.
• Ensure uniformity across states: Stakeholders also recommended establishing a nationwide IT platform to ensure uniform processes for licensing, inspection, and quality assurance across states, aiming for consistent medicine quality throughout the country.

What are the major changes?

• The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain the quality of medicines produced.
• Focus on Quality: Companies will now be required to
• conduct regular quality reviews for all products,
• ensure consistency in quality and processes,
• thoroughly investigate deviations or suspected defects, and
• implement preventive actions.
• Additionally, a change control system will evaluate any modifications affecting production or product quality.
• Documentation: The guideline emphasizes proper documentation practices to meet global standards.
• Stability studies: The companies will also have to carry out stability studies as per the climate conditions.
• The companies will be needed to mandatorily maintain the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well.
• Implementation of GMP-related computerized systems: The guidelines stipulate that companies must implement GMP-related computerized systems to safeguard data from tampering.
• These systems serve as barriers against unauthorized access and changes to process-related data enhancing the accuracy and reliability of records.
• Accuracy: Sensitive data manually entered into the system will undergo additional validation checks, confirming the precision of the input.

How will the changes help?

• Quality: Instituting the same quality across the industry will give confidence to regulators from other countries and will improve the quality of drugs in the domestic markets.
• Reduce repeated inspections: It will ensure that all the manufacturing units in the country are at par with global standards, thereby reducing the need for repeated inspections by different regulators.
• This initiative will position India as a quality pharmaceutical hub of the world. Moreover, it guarantees that our citizens will access medicines of export-quality medicines.
• Implementation: The bigger companies with a turnover of over 250 crores will need to implement these measures within six months and smaller companies within a year.

What are the issues?

• Impact on smaller companies: The smaller companies have to make drastic changes within a year which may lead to increased expenses for the company and reduce their profitability.
• Compounding: Under this amendment, companies violating certain provisions will still face potential imprisonment and fines, but they have the option to pay a fine instead of going through a court trial.
  • Compounding allows companies to pay a fine instead of undergoing criminal proceedings.
• The new amendment raises questions about whether penalties for violations like drugs leading to death or injury, adulterated medicines, and spurious medicines should be subject to compounding.

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FAQs

MCQ

Question: With reference to Central Drugs Standard Control Organisation (CDSCO), consider the following statements

1. It is the National Regulatory Authority (NRA) of drugs in India.
2. It is responsible for the approval of New Drugs, Conduct of Clinical Trials

Select the correct answer using the code given below:

(a) 1 only

(b) 2 only

(c) Both 1 and 2

(d) Neither 1 nor 2