In a strongly worded letter to the Union Health Ministry, the Rashtriya Swayamsewak Sangh- (RSS) backed Laghu Udyog Bharati, which represents over 300 micro and small industries across India, has said the Union government’s risk-based inspections (RBI) on pharma companies were draconian and have been a huge discouragement to the pharma industry.
Stating that such inspections bring a bad name to the Indian pharma industries, the group demanded these be stopped immediately and the entire procedure be reworked before being initiated again.
The letter, accessed by The Hindu, titled ‘Risk-based inspections— A death sentence for MSME pharma manufacturers in India’, was sent to the Ministry last month and signed by Sanjay Kumar, president, Laghu Udyog Bharti.
When contacted on July 6, Mr. Kumar said the letter was “sent by mistake” and added that a clarification had been issued.
“This wasn’t meant to be sent to the Ministry as this was just a topic of discussion in our internal meeting.” He added that the letter’s content shouldn’t be considered the view of all office-bearers of the organisation as the same is yet to be discussed with all.
Major crackdown
Since early this year, the Health Ministry has been coming down heavily on pharma companies and has conducted inspections in over 100 firms as part of a massive nationwide crackdown on spurious and substandard medicines. Licenses of over 18 pharma companies have been cancelled and some firms have been directed to stop manufacturing on account of poor-quality medicines.
A majority of the companies were operating out of Himachal Pradesh, Madhya Pradesh and Uttarakhand.
Meanwhile, the latest letter stated how the Government of India, through the Central Drugs Standard Control Organisation (CDSCO) and State regulators, has started carrying out nationwide inspections at pharma units following a risk-based approach.
The RSS-affiliate body mentioned how the entire premise of shortlisting the units for such inspections was based on “Not of Standard Quality Drugs” (NSQ) declared by government labs, and that it has many faults. The letter, which has five points, added that the shortlisting of these firms was not transparent.
“The scale of RBls has brought a bad name to the Indian pharma industry,” the letter said, adding that media reports have also echoed the same by stating that India has been having a big crackdown on industries manufacturing NSQ.
“For the general public of India and for the consumers of Indian drugs across the globe, this gives a message that all Indian drug manufacturers are involved in the manufacturing of spurious, adulterated and NSQ drugs. Hence, the image of the pharma industry is completely being destroyed due to constant media coverage,” the letter said further, adding that the RBls should have been considered as routine inspections rather than a special drive.
‘Threatening to industry’
Pointing out that India is known as the ‘pharmacy of the world’ thanks to its production of affordable medicine, which is possible only due to a large number of MSME industries, the body said that inspection by large teams with a mindset of fault-finding was intimidating and threatening to the industry facing the audit.
“In most of the cases, the SQs are taken to courts for prosecution. Such activities or actions taken against the manufacturer will lead to a decrease in the chances of a fair trial. The courts will definitely be biased as the public prosecutors will not leave any opportunity to highlight the outcomes of these inspections to show the industries in a bad light and impress upon Honorable Judges to take a favourable decision and put the complete case of defence in a position of disadvantage,” the letter further said.
“This drive has its heart at the right place, but the entire procedure of shortlisting, conducting, reporting etc. should be done objectively and in a friendly manner. Hence, for the time being these inspections should be immediately stopped,” the letter said.
