Revised GMP guidelines for Pharma in India

The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards. Larger companies with a turnover of over Rs. 250 crores have been asked to implement the changes within six months, while medium and small-scale enterprises with turnover of less than Rs. 250 crores have been asked to do so within a year.

What was the need for the improved standards?

The following are the major changes in the revised manufacturing rules:

1. The new guideline introduces pharmaceutical quality system, quality risk management, product quality review and validation of equipment and also suggests a change control system to evaluate all changes that may affect the production or quality of the product
2. As per the revised rules, 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”
3. The guidelines also state that, companies should have GMP-related computerized systems to ensure that there is no tempering of data related to the processes. Such GMP systems will prevent unauthorized access and changes to the data. Backups would also be created to ensure there is no loss of data
4. In addition, the new schedule M also lists out the requirements for additional types of products, such as biological products, agents with radioactive ingredients or plant-derived products
5. Also this gives the requirement for investigational products being manufactured for clinical trials
6. The improved standards will ensure that pharmaceutical companies follow standard processes, quality control measures, and do not cut corners, improving quality of medicines available in India as well as sold in global market.

How will the changes help:

1. Instituting the same quality across the industry
2. Will improve the quality of drugs in the domestic markets
3. It will help the govt., to ensure all the manufacturing units in country are at par with global standards
4. And reduces the need of repeated inspections by different regulators
5. It will make India a quality pharmaceutical hub of the world

When will the changes be implemented?

August 1 onwards (by Union Health Minister)

Bigger companies will now have six months and smaller companies will have a year to implement the changes.

The new schedule M, however, is yet to be notified, say experts.

A drug manufacturer said: “Initially when the draft guidelines were released, the industry said that at least 36 months would be needed to make the necessary changes. The deadline of one year might get extended. However, it is the smaller companies who have to make drastic changes, most bigger companies in India already follow the global GMP.”

To help such companies, the department of pharmaceuticals also has a scheme to provide credit-linked capital and interest subsidy for upgradation of MSME units.