Health

Indian pharma firms receive 34% of FDA warnings this year

These warnings were for misbranding, selling unapproved medicines and violating Current Good Management Practices

 
By Rohan Gupta
Last Updated: Wednesday 21 August 2019
Warnings letters to Indian pharmaceutical companies by the FDA have been historically high. Photo: Getty Images
Warnings letters to Indian pharmaceutical companies by the FDA have been historically high. Photo: Getty Images Warnings letters to Indian pharmaceutical companies by the FDA have been historically high. Photo: Getty Images

Indian pharmaceutical companies received a third of the warnings the United States Food and Drug Administration (FDA) issued for misbranding, selling unapproved medicines and violating Current Good Management Practices (CGMP) so far this year.

The FDA issued 38 warnings to pharmaceutical companies in 2019 (as of August 21) and of these, 13 (34 per cent) were to Indian companies including major players like Emcure Pharmaceuticals Ltd and Aurobindo Pharma Ltd, according to FDA records. Pharma companies in the US received most of these warnings — 15.  

According to section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) violations of CGMP by a drug manufacturer can result in its product being categorised as adulterated. Management oversight, non-conformity to standards, batch failures, contamination are some of the constituents of CGMP violations.

The reason for such high number of warning letters to India is the relatively higher number of inspections done in the country, Sudarshan Jain, general secretary, Indian Pharmaceutical Alliance, told Down To Earth.

“India is the biggest exporter to the US market,” Jain added while giving a reason for the high number of inspections. But, according to United States International Trade Commission data, India is the fourth largest exporter of pharmaceutical products to USA.

When asked again, he said, “India ranked second in terms of volume (59 million kilogramme) in 2015, according to US Department of Commerce. This website has changed format and does not provide volume data anymore.”

The charges against these 13 companies are:

Charges

Companies

Type of Product

Violation of CGMP/Adulteration

Emcure Pharmaceuticals Ltd

Finished Pharmaceutical product

Lantech Pharmaceuticals Ltd

Active Pharmaceutical Ingredient (API)

Indoco Remedies Ltd

Finished Pharmaceutical product

Strides Pharma Science Ltd

Finished Pharmaceutical product

Aurobindo Pharma Ltd

API

Rxhomeo Pvt Ltd

Finished Pharmaceutical product

Glint Cosmetics Pvt Ltd

Finished Pharmaceutical product

Centurion Laboratories Pvt Ltd

Finished Pharmaceutical product

B. Jain Pharmaceuticals Pvt Ltd

Finished Pharmaceutical product

Anicare Pharmaceuticals Pvt Ltd

Finished Pharmaceutical product

Jubilant Generics Ltd

Finished Pharmaceutical product

Hospira Healthcare India Pvt Ltd

Finished Pharmaceutical product

Vipor Chemicals Private Ltd

API

Misbranding

Glint Cosmetics Pvt Ltd

Finished Pharmaceutical product

Anicare Pharmaceuticals Pvt Ltd

Finished Pharmaceutical product

Marketing Unapproved medicines

Glint Cosmetics Pvt Ltd

Finished Pharmaceutical product

Repeat offenders

This phenomenon has been consistent across the last five years as some of these 2019 recipients are repeat offenders, said Dinesh S Thakur, a public health activist and the whistleblower who helped authorities unravel malpractices in Ranbaxy.

"It all boils down to profits and the fact that there is inadequate oversight of cutting corners and lack of any accountability towards patients who consume these so-called medicines,” Thakur told DTE.

Two companies of the warned companies had received letters from the US food drug regulatory authority before this, showed FDA records. Emcure was warned in 2016 and Indoco in 2017. Indoco Pharmaceuticals was also asked to engage a CGMP consultant twice, in 2017 and 2019.

Warnings letters to Indian pharmaceutical companies by the FDA have been historically high, with the share going up to 50 per cent in 2015. 

“Most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of Central Drugs Standard Control Organisation (CDSCO)," read the 59th Parliamentary Committee report.

"For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured,” it added.

Moreover, the contents of the warning letters bring out certain patterns of violations indicating industry-wide problems.

Quality control

Seven of the 13 companies were pulled up for having inefficient quality control units. The warning letters stated that quality control units in B Jain Pharma, Strides Pharma and Glint Cosmetics either did not provide adequate oversight or lacked appropriate control over quality testing of products.

In the case of Strides pharma, the inspectors found evidence of uncontrolled shredding of documents and discarded CGMP documents, some of which were just seven days old.

The FDA inspectors also found that Rxhomeo had not tested incoming materials for quality and Jubilant Generics had not conformed to appropriate testing procedures in production process. Indoco’s and Anicare Pharma’s quality control units were found to be inadequate too.

API contamination

Maintenance oversight with respect to active pharmaceutical ingredient (API) contamination was a recurring charge against all three API manufacturers — Lantech Pharmaceuticals Ltd, Aurobindo Pharma and Vipor Chemicals Pvt Ltd.

The USFDA letter to Vipor highlighted its “failure in establishing and following adequate written procedures for cleaning equipment and release for use in the manufacture of API”.

Lantech was also found to have followed inadequate cleaning procedures. According to the warning letter to Aurobindo, it had “failed to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications”.

Data integrity

The FDA found that Hospira Healthcare, Centurion Laboratories and Indoco Remedies didn’t maintain laboratory records properly.

It was also observed that Glint Cosmetics and Rxhomeo didn’t have proper control to ensure that only authorised personnel instituted changes in master production and control records. Strides Pharmaceuticals was also asked to remedy their data management techniques for better compliance with FDA standards.

Cleanliness

FDA inspectors learnt that Centurion and Anicare Pharma had failed to “follow written procedures for cleaning and maintenance of equipment”. B Jain Pharma had also failed to clean and maintain appropriate sanitation and it didn’t sterilise equipment and utensils at appropriate intervals.

Even though the share of FDA warning letters to Indian BioPharma companies has shrunk, the industry has a long way to go.

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