Factory certification may be mandated for all drugmakers

The move comes even as India’s drugs regulator has sought to crack down on poor quality drugs.

The Union government is likely to make good manufacturing practice (GMP) mandatory for all units manufacturing drugs in the country to maintain quality of drugs produced and exported from India, people familiar with the matter said.

According to the World Health Organisation, governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical manufacturers and by training their inspectors in GMP requirements.

“The government is looking at gradually making it mandatory for companies manufacturing drugs to follow good manufacturing practice. Currently, it is meant to be in place for those wanting to export drugs to other countries,” said a senior government functionary, requesting anonymity.

The move comes even as India’s drugs regulator has sought to crack down on poor quality drugs -- following complaints from countries such as The Gambia, Uzbekistan and the US about India-made drugs. Even as it has sought to protect India’s interests overseas, the health ministry, through the drugs regulator, has sought to make changes in the monitoring and regulatory regime to address the problem. GMP, analysts say, is the logical next step.

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. Most countries make it a condition for the import and sale of medicines .

According to the World Health Organisation (WHO), governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical manufacturers and by training their inspectors in GMP requirements.

The guidelines are meant to minimise the risks involved in the production process that cannot be eliminated through testing the final product.

The main risks include unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production -- from the starting materials, premises and equipment to the training and personal hygiene of staff.

And it involved documentation. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process -- every time a product is made.

WHO has established detailed guidelines for good manufacturing practices that companies should follow in their drugs manufacturing units to maintain quality of products. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations, in the European Union and through the Pharmaceutical Inspection Convention.

According to WHO, GMP is designed to ensure that mistakes do not occur.

“Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer,” it says in its document on GMP guidelines.

A section of experts, however, is a bit sceptical about its implementation.

“We have seen this argument made many times before and yet we see what we see in the market. This is a distraction. Also, don’t the export oriented manufacturing units already comply with WHO GMP standard?” senior pharma expert Dinesh Thakur said.

To ensure quality of drugs being produced in India is maintained well, the Centre had conducted a Chintan Shivir (deliberation camp) in Hyderabad in February this year with state representatives and representatives of the state drugs regulators. As a part of the two-day camp, the brainstorming sessions were conducted with a view to evolve a participative approach for time-bound implementation of policies and programmes.