Expert says several firms may be producing drugs with quality control issues, Maiden Pharma not alone

The Haryana government has decided to halt production at Maiden Pharma's Sonepat plant. It has also issued a 5-page showcause notice listing 12 violations to the company. Maiden Pharma has a week to respond to this notice.

The company is in the dock after the deaths of 69 children in the Gambia were linked to their cough syrups. The World Health Organisation has told CNBC-TV18 that unlike what the pharma company claimed earlier, the agency had not inspected or assessed any of its products.

Prashant Reddy T, lawyer and co-author of The Truth Pill believes that Maiden Pharma may not be an isolated incident. He said there could be several other companies that could be producing drugs with quality control issues.

"A lot of the small and medium pharma companies do not have a separate quality control department which is mandated under the GMP. So if the government makes inspection reports of the company’s public, I am sure we will find several other companies which are in violation of the law," Reddy said.

He told CNBC-TV18 that the CDSCO came up with guidelines on drug recall in 2012 but with no binding effect, "There has been a debate in India since 1976 on the need for a national drug recall law. Currently, regulation is fragmented across the country and each state has its own regulator, they don’t have powers to operate in another state."

"The CDSCO itself plays a very limited role and so when you want to affect a national recall, you need agencies with the power to enter premises, search and seize stock without worrying about territorial boundaries. In 2012 the CDSCO came out with a set of recall guidelines that lack any force of law. So since 2012, the CDSCO has been discussing how to translate the guidelines into law. It is not rocket science to translate the guidelines into binding law, it is just that they don’t want to do it. If you see the CDSCO’s track record, they will do anything to avoid any form of accountability when it comes to ensuring the public health of Indian people," he said.

According to Reddy, data integrity has been an issue with the Indian pharmaceutical industry for a long time. He said Indian pharmaceutical companies simply do not comply with good manufacturing practices (GMP).

"The essence of GMP is to record data in a timely manner, where records cannot be tampered with in the future. So the fact that there may be data integrity issues at this plant, will not surprise anybody who is familiar with the workings of the Indian pharmaceutical industry," he added.