GMP compliance in India is a work in progress!

Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume. This article examines how well they comply with Good Manufacturing Practices (GMP).

The International Conference on Harmonization defined Good Manufacturing Practices in their Q7A Guide for Active Pharmaceutical Ingredients. This guide was adopted by the ICH Member Countries including the European Union, Japan, the United States, Australia, Canada and Norway. India is conspicuous by its absence from the ICH Conference.

The Q7A guide for GMP compliance is quite large, but the basics can be boiled down to a few key points. Instructions and procedures must clear and unambiguous, and most of all written down in standard operating procedures (SOPs). Manufacturing processes have to be clearly defined and controlled and records demonstrate that all required steps were taken. Facilities have to be designed to minimize cross-contamination and mix-ups. Operators have to be trained and their training documented. Finally it has to be shown that distribution of the drugs to the patients minimizes any risks.

While the GMP guide is very complete, there are different approaches to GMP compliance depending on each country. There are quite large differences in quality and compliance in different countries. In general, a nation’s relative state of development dictates the level of compliance they can afford. Countries who are ICH signatories have the best quality. BRIC nations including India generally are struggling with the cost of compliance, even though they recognize the value of GMP compliance for selling their product internationally.

So how do we know “What is GMP in India”? There is a world wide standard for GMP inspections. It’s called the Pharmaceutical Inspection Cooperation Scheme. That scheme references “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A). Participants in this cooperation scheme include Australia, Canada, Eastern Europe, EU, Malaysia, SA, Singapore, UK, US and Taiwan. India is not one of the participating countries.

There are GMP inspections occurring in India. The FDA does conduct facility inspections for products that are going to be sold in the US. Their inspections don’t include clinical trial manufacturing or facilities used to make just clinical stage products or products to be sold locally. So far, about 100 Indian facilities have been inspected by the FDA. For all others, India relies on their own local GMP inspectors.

GMP compliance in India is highly influenced by government and business conditions. Pharmaceutical companies in India don’t pay taxes for their first ten years which is why there are over 20,000 pharmaceutical companies there. Also, pharmaceutical companies don’t have to go through a complex certification procedure. The FDA only conducts facility inspections only for products to be sold in the US, the rest are left to local inspectors.

This has resulted in many GMP facilities in India that very far below international standards. Up to 1970, Schedule M of India’s Drug & Cosmetics Act covered only the pharmaceutical company’s location, buildings, equipment, safety and sanitation. When GMP requirements were introduced worldwide, it covered the gaps in Schedule M. The pharmaceutical manufacturers lobbied in India saying the the Schedule M regulations were harmful to the small players in the pharmaceutical industry. The amendment of Schedule M of 2005 which is consolidates with international GMP is more lenient compared with what the US and EU require. While small and medium size enterprises are still in the process of adopting GMPs, they are asking to make the existing GMPs even more relaxed. The Indian administration has been considerate of the plight of the small and medium size enterprises. They know that small pharmaceutical companies might be shutdown in some states if all the requirements of GMP are enforced so the government is cutting them some slack.

There is a way to help out small India pharmaceutical companies using software that makes GMP compliance easy. For example, a manufacturing execution system with electronic batch record system can streamlines the entire end-to-end production of GMP materials. If it is CFR 21 Part 11-compliant software which means it complies with the FDA requirements for electronic signatures and electronic documentation, it can use a web-based infrastructure that can be accessed from anywhere. This means users don’t have to install anything on their servers. They just need an internet connection to use it. All data is automatically visible to everyone at the same time and can be monitored in real time. Software that was designed to maintain quality compliance automatically can help makes any facility GMP compliant.

There are a few key messages to take home from this article. In general no one GMP compliance system exists even in countries that are signatories to ICH. India does wants to become compliant, but they have a long way to go before all of their industry is fully GMP. Most GMP facilities in India are struggling to pay for the cost of compliance. If you need GMP manufacturing in India, you have to monitor closely to assure they are in compliance unless the FDA or other regulatory agencies has approved them for making your product.

Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com MES, an electronic manufacturing execution system that is web based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Author Bio: Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Medical Business
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record