Government asked Pharma companies to adopt WHO-standard good manufacturing
ContextTo overcome the deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP), and bringing them on par with World Health Organisation (WHO) standards.
About the Step:
- According to Health Ministry, the Companies with a turnover of over 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
- Need: In India, only 2,000 of the 10,500 manufacturing units were found to be compliant with the global WHO-GMP standards.
- The GMP-WHO rule combination for Indian Pharmaceuticals will lead to at least 11 specific changes in the manufacturing process on the ground, including introduction of a pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
- The companies will also have to introduce a GMP-related computerized system.
- These computer programmes will be designed to automatically record all the steps followed and checks done, which will ensure all the processes are followed.
- The companies will also have to carry out stability studies as per the climate conditions which includes that, they will have to keep the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well.
|Accelerated stability test:
- Significance of the Step:
- It will ensure that all the manufacturing units are at par with global standards, reducing the need for repeated inspections by different regulators.
- It will also make India a quality pharmaceutical hub, and ensure that our citizens receive export-quality medicines too.
- Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
- Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP.
- Governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
- WHO’s Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
- GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production; which may broadly be categorized into two groups:
- cross-contamination/mix (ups and
- False labelling.
- Manufacturers must not place patients at risk due to inadequate safety, quality or efficacy.
- For this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
- India follows the guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- ICH brings together the medicines regulatory authorities and pharmaceutical industry around the world.
- ICH was founded in 1990 which brings together the regulatory and pharma industry authorities. Together they create the ICH guidelines.
|ICH’s mission has been embodied in its Articles of Association as follows: