Economy

Government asked Pharma companies to adopt WHO-standard good manufacturing

Table of Contents

Context
To 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:
  • Accelerated stability testing increases the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing program.
  • 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.
What is Good Manufacturing Practices (GMP)?
  • 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 GMP guidelines:
  • 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’s GMP rules:
  • 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:
  • To make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations;
  • To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products;
  • To contribute to the protection of public health in the interest of patients from an international perspective;
  • To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data;
  • To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;
  • To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices;
  • To encourage the adequate implementation and integration of common standards through the dissemination of, the communication of information about and coordination of training on, harmonised guidelines and their use;
  • And to develop policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA) whilst ensuring the scientific and technical maintenance, development and dissemination of MedDRA as a standardised dictionary which facilitates the sharing of regulatory information internationally for medicinal products used by humans.
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