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Pfizer whistleblower’s claims: NHRC asks govt to respond

The whistleblower sent an e-mail to various government institutions, including KSHRC, on August 11, 2015. After “perusing” the e-mail, the KSHRC decided to transfer the complaint to the NHRC on October 13, 2015.

Written by Deepak Patel | New Delhi |
February 13, 2017 12:03:16 am

Illegally importing and misbranding kidney cancer drug Torisel in India; selling a steroid named Medrol with an extended expiry date not permitted under the law; and not testing its popular pneumococcal vaccine Prevenar as per norms — these are the key allegations of a whistleblower against pharmaceutical giant Pfizer that have prompted the National Human Rights Commission (NHRC) to send three letters to the Union health secretary in the last one year seeking a report.

The whistleblower sent an e-mail to various government institutions, including the Karnataka State Human Rights Commission (KSHRC), on August 11, 2015. After “perusing” the e-mail, the KSHRC decided to transfer the complaint to the NHRC on October 13, 2015.

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The NHRC wrote letters on February 27, 2016, and May 12, 2016. In its third letter dated November 14, 2016, the NHRC said that it didn’t receive any report despite a reminder. Taking a “serious view”, it further asked for a submission by December 15, 2016, failing which, it said, would invoke the provisions of Section 13 of the Protection of Human Rights (PHR) Act, 1993. This section of the Act gives the NHRC powers of a civil court.

In a reply to an RTI application filed by The Indian Express, the health ministry said on January 20, 2017 that “no response has, so far, been sent to NHRC on the above matter”.

When asked about the complaint, K L Sharma, joint secretary, Ministry of Health, said that the ministry did not deal with “day-to-day operational activities relating to regulation of drugs which is a role vested in the Central Drugs Standard Control Organisation (CDSCO)/state Licencing Authorities under the law. The Ministry is only concerned with policy related matters. Scores of regulatory actions are taken in each state by drug regulatory officials and these are disposed of by them in terms of powers vested in them.”

A Pfizer spokesperson said that it “places the utmost emphasis” on patient safety and product quality. “We shall not deal with such issues in any manner that is not ethical or compliant with our standards of governance and way of doing business. All Pfizer products meet every national and international testing specification,” said the spokesperson.

On February 27, 2016, the NHRC had sent the first letter to the then health secretary Bhanu Pratap Sharma, currently the secretary of the Department of Personnel and Training (DoPT), asking him to submit a report on it within four weeks. After getting no response, another ‘reminder’ was sent to him on May 12, 2016.

Bhanu Pratap Sharma did not respond to a query by The Indian Express as to why he didn’t submit the report to the NHRC during his tenure.

C K Mishra, who replaced Sharma as the health secretary on July 28 last year, did not respond to the same query by The Indian Express.

However, K L Sharma acknowledged that Mishra received the e-mailed queries from The Indian Express.

K L Sharma said: “It has been informed by CDSCO that while some of the matters have been agitated in high courts (HCs) of Mumbai, Odisha, Karnataka, Tamil Nadu and Delhi, appropriate orders have been issued by the competent authorities either in accordance with the directions of the HCs or otherwise. In cases where the matters have been agitated in courts, the facts brought out in the whistleblower’s application or drug inspectors reports had been duly considered by the courts.”

Key allegations

Torisel: The drug, illegally imported in India, didn’t have an import licence for 30 mg. The drug, under the label Wyeth Elderly, Italy, is manufactured by Pierre Fabre Medicament Production Avenue du Bearn and therefore, is deemed to be a spurious drug under Drugs and Cosmetics Act. Wyeth is a subsidiary of Pfizer.

A single injection of Torisel (25 mg) is available in India for approximately Rs 70,000.

A Pfizer spokesperson said: “With regard to Torisel, contract manufacturers like Pierre Fabre and others provide Pfizer with semi-finished goods with which Pfizer manufactures the finished products. This is not only an industry practice but also recognized by the Indian drug laws.”

Medrol: Many batches of this drug mentioned expiry dates beyond five years and the CDSCO did not take appropriate action on it.

However, G N Singh, Drug Controller General of India (DCGI) who heads the CDSCO, had issued a notice dated September 15, 2015, rejecting Pfizer’s proposal to extend the expiry date of Medrol beyond five years. As per the law, no drug is allowed for more than 5 years. On May 18, 2016, the Delhi High Court asked Pfizer to withdraw stocks of its already-imported Medrol six months before the expiry period of 5 years.
The spokesperson further added that the matter regarding Medrol pertained to certain batches expiring in 2019 where the labelling format was being interpreted to convey one additional month of shelf life and was closed with Delhi HC’s 2016 order that allowed Pfizer to continue marketing these batches.

G N Singh did not reply to the queries of The Indian Express.

Prevenar: The whistleblower said the vaccine is not tested as per European Pharmacopoeia (EP) as stated in the label.

Currently, a Prevenar 13 injection (1 ml) is available in Indian market at approximately Rs 3,800.

The spokesperson added that Pfizer fully complies with Drugs and Cosmetics Act. “The monograph of the vaccine is given in the EP and the same is followed during the quality testing process,” she added.

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