Good Manufacturing Practices (GMP) for Pharma Companies

What’s in today’s article?

• Why in News?
• What are the Good Manufacturing Practices (GMP) for Pharma Companies?
• Need for the Revised GMP
• What are the Major Changes in the GMP?
• Significance of the Revised GMP
• Concerns Raised by Pharma Industry and Way Ahead

Why in News?

• The Government of India recently directed all pharmaceutical companies in the country to implement the revised GMP, bringing their processes at par with global standards.
• Larger companies (turnover > Rs 250 crore) have been asked to implement the changes within six months, while medium and small-scale enterprises (turnover < Rs 250 crore) have been asked to do so within a year.

What are the Good Manufacturing Practices (GMP) for Pharma Companies?

• GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
• It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
• The World Health Organisation (WHO) has established detailed guidelines for GMP and many countries have formulated their own requirements for GMP based on WHO GMP.
• Others (such as the ASEAN, EU) have harmonised their requirements through the Pharmaceutical Inspection Convention.

Need for the Revised GMP:

• Poor quality of Indian manufactured drugs: There have been incidents where countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments.
  • For example, the deaths of 70 children in the Gambia, 18 children in Uzbekistan, 3 persons in the US, etc., have been linked to these products.
  • Only 2,000 of the 10,500 drug manufacturing units in the country at present meet global standards, being WHO-GMP certified.
• A risk-based inspection found several deficiencies: For example,
  • Incoming raw materials not being tested before use,
  • Product quality not being reviewed,
  • Absence of quality failure investigation,
  • Infrastructure deficiency to prevent cross-contamination,
  • Faulty design of manufacturing and testing areas, missing qualified professionals, and
  • Poor documentation.

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What are the Major Changes in the GMP?

• The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain quality of medicines produced.
• The new guideline introduces pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
• This will mean companies will have to carry out regular quality reviews of all its products, verify consistency of the quality and the processes.
• It also suggests a change control system to evaluate all changes that may affect the production or quality of the product.
• The companies will also have to carry out stability studies as per the climate conditions.

Significance of the Revised GMP:

• It will bring the Indian industry on par with global standards, improving the quality of medicines available in India as well as sold in global markets.
• This comes at a time when India is promoting itself as the global manufacturing hub for generic medicines.
• The GMP-related computerised systems will ensure that there is no tampering of data related to the processes.
• Instituting the same quality across the industry will give confidence to regulators from other countries.

Concerns Raised by Pharma Industry and Way Ahead:

• It is the smaller companies who have to make drastic changes, as most bigger companies in India already follow the global GMP.
  • Therefore, at least 36 months would be needed to make the necessary changes.
• To help such companies, the department of pharmaceuticals has a scheme to provide credit-linked capital and interest subsidy for upgradation of MSME units.

Q1) What is the World Health Organisation (WHO)?

Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.

Q2) Why is India called the pharmacy of the world?

India is hailed as the “Pharmacy of the World” owing to its high and efficient production of “global standard medicine” at affordable costs.

Source: Revised manufacturing rules for drug firms: what changes, and why