Drugs manufactured by pharmaceutical company, Theon Pharmaceuticals Ltd – owned by railway minister Pawan Kumar Bansal's wife Madhu and son Amit – were found to be 'not of standard quality' by the Drugs Control Laboratory of Maharashtra, documents accessed by dna have revealed.
Drugs manufactured by pharmaceutical company, Theon Pharmaceuticals Ltd – owned by railway minister Pawan Kumar Bansal’s wife Madhu and son Amit – were found to be ‘not of standard quality’ by the Drugs Control Laboratory of Maharashtra, documents accessed by dna have revealed.
A parliamentary standing committee had also raised concerns over the clinical trials conducted on the drugs manufactured by the company, which is based in Panchkula, Haryana.
In May 2012, the lab observed that drug samples from the company do not meet the Indian Pharmacopoeia 2010 standards. Indian Pharmacopoeia Commission (IPC) – an autonomous body under the ministry of health and family welfare – sets the standards for composition of all drugs that are manufactured, sold and consumed in India. The standards are published periodically under the title Indian Pharmacopoeia, and IP 2010 has been in force since December 1, 2010.
“Content of clavulanic acid in the sample is less (56.08% of the labelled amount) than the IP 2010 limits. The sample does not comply with IP 2010 requirements for pH test,” the lab said after a month-long analysis of two samples. Clavulanic acid is used to kill bacterial species that tend to develop a resistance to antibiotics.
Asked to comment on whether corrective action was taken after the IPC’s findings, the company’s whole-time director Punit Bansal ducked the query. He also refused to comment on other queries related to the issue.
The company had also violated the IP standards in the past. According to the laboratory’s June 2011 findings, the company’s drugs had failed to meet the IP 2007 standards as well.
“Content of Amoxicillin in the sample is less (79% of the labelled amount) than the IP 2007 limits,” the lab observed. Amoxicillin is used to treat infections such as pneumonia, skin infections, urinary tract infections and anthrax.
Interestingly, almost the entire family of the railway minister is on the company’s board. His wife Madhu and daughter-in-law Monika are whole-time directors, his son Amit is the managing director, while his other son Manish is the director.
According to records of the ministry of corporate affairs, Amit and Monika were appointed in November 2006, while Madhu was appointed in April 2010. A total of 11 family members are on the board. The clout that the family name generated may have yielded approvals for drugs, which came to the attention of a parliamentary panel last year.
A parliamentary standing committee on health and family affairs said the Central Drugs and Standards Control Organisation had not conducted the third phase of clinical trials of the company’s drugs properly. A report tabled in Rajya Sabha in April 2012 states that the mandatory phase three clinical trials, conducted on 1,000-3,000 people, were not done in case of certain drugs manufactured by Theon Pharmaceuticals.
In an observation, the committee also said certain drugs manufactured by the company did not have permission to sell in major developed countries and none of these drugs had specific relevance to the medical needs in India.
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