Rashtriya Swayamsevak Sangh affiliate Laghu Udyog Bharati wrote to the central government to immediately “stop” inspections at pharmaceutical firms, calling these much-required checks a “death sentence” for micro and small firms. The organisation later retracted the letter saying it was sent due to “some confusion”.
The letter titled ‘Risk-based inspections – A death sentence for MSME pharma manufacturers in India’, was sent to the health secretary. Accessed by News18, the letter alleged that the entire procedure of conducting inspections is flawed and, in fact, they are destroying the reputation of the Indian pharmaceutical industry.
In its letter, the Laghu Udyog Bharati (LUB), which representing micro and small industries in over 400 districts, said “draconian risk-based inspections is unjust and, in a way, huge discouragement to the pharma industry”.
“…For the time being, these inspections shall be stopped immediately and the entire procedure shall be reworked before initiating this process again,” said the letter written by LBU president Sanjay Kumar.
It added: “India is known as the ‘Pharmacy of the World’ due to its affordable medicine, which is possible only due to the large number of MSME industries.”
The ministry of health and family welfare via its drug regulatory wing, Central Drugs Standard Control Organisation (CDSCO), has been conducting inspections at certain shortlisted companies. These are called risk-based inspections (RBIs) and were triggered after the World Health Organization and several other countries, including Gambia, Uzbekistan, Marshall Islands and Micronesia and the US, raised doubts over the quality of Indian medicines.
A top official at the health ministry confirmed the receipt of the letter. “The letter was forwarded to CDSCO to address concerns,” the official said.
The LBU president, however, told News18 that a “clarification” was later sent to the ministry. “The idea was to collect points for an internal meeting. However, due to some confusion, it was couriered to the health secretary. We later sent a clarification to the ministry explaining the confusion,” he said, without divulging the details of the clarification.
‘Image of pharma industry destroyed’
The LUB praised Prime Minister Narendra Modi for projecting India as a “pharmacy to the world” on multiple platforms. But said, “These large-scale risk-based inspections (RBIs) have brought a bad name to the Indian pharma industry.”
“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 not-of-standard quality drugs,” it said.
It added: “Hence, the image of the pharma industry is completely being destroyed due to constant media coverage.”
The LUB also blamed the inspectors conducting the drive. The letter said, “Inspection by large teams with a mindset of fault finding is intimidating and threatening to the industry facing the audit.”
‘Fault in method of inspection’
The organisation also blamed the Centre for choosing a faulty procedure – based on ‘not of standard quality drugs’ (NSQ) – for shortlisting the companies for RBIs. While it praised the Centre for its genuine effort to take India’s pharmaceutical industry to the next level, it listed flaws in the scheme.
The premise of shortlisting the companies for inspections is based on NSQ drugs declared by the government in a year. “After shortlisting, these units are inspected, reported and subsequent actions are taken against these industries,” the letter stated.
“Sir, here we would like to highlight glaring issues in the entire process of shortlisting, conducting, reporting and actions being taken during these risk-based inspections,” it said.
It added: “The government has not considered the category of NSQs, which are divided into ‘spurious and adulterated drugs’ (Category A), ‘grossly sub-standard drugs’ (Category B) and ‘minor defects’ (Category C).”
The letter alleged that during shortlisting, no emphasis was given on the categorisation. “The shortlisting is based on the number of NSQs received,” it said.
“We understand if Category A cases are shortlisted for RBI but Category B shall not be considered for the same unless the defects are critical,” it added. “In the case of Category C defects, the guidelines only suggest taking administrative measures.”
‘MSME unable to cope with inspections’
According to the letter, the micro and small pharma firms are unable to “cope” with the inspection teams. “As per procedure laid down, normally a team consists of a minimum of 3 to 6 to 7 inspectors deputed in premises for 3 days,” it stated.
“This is roughly equivalent to 12-15 days in a particular industry. Small-scale industries normally do not have a huge staff to handle such a big team. And constant questioning leads to their crumbling under pressure,” the letter said. (sic)
“Due to this, many times, the facilities even being compliant with many of the requirements face difficulty in satisfying the inspectors. This dissatisfaction leads to observations which shall not be there in the first place,” it said.
The letter also commented on the “attitude of inspectors” calling them “totally different during the conduct of these RBIs”. “Normally, they do have a guiding as well as hand-holding approach; however, while carrying out RBIs, we are often perceived as criminals and culprits by them,” it said.
“We have always welcomed the inspections as they are informative and suggestive when carried out in good harmony,” it added.
In a subhead – ‘Threatening to manufacturing firms’ – the letter said the inspection by large teams with a mindset of fault finding is intimidating and threatening to the industry facing the audit.
“The constant fear of adverse reporting and losing their bread and butter along with the bread and butter of hundreds of employees working for them is terrifying,” the letter stated.
‘Punish inspectors who certified units with WHO-GMP standards’
The letter further claimed that many of the industries are WHO-GMP certified “which means that such industries are found meeting the criteria equivalent to WHO standards by a team of inspectors of both CDSCO and State Licensing Authorities”.
“Normally, WHO standards are considered more stringent and detailed than the Schedule M standards,” the letter said. “How is it possible that the said industries, which were declared as WHO GMP certified, will now be struggling to meet Schedule M standards?”
Schedule M part of the Drugs and Cosmetics Act, 1940, deals with good manufacturing practices for pharmaceuticals that should be followed by manufacturing units in India.
“If an industry fails miserably to meet Schedule M standards now and were declared as WHO GMP by a previous team of inspectors then why does only a firm have to face all the consequences?” the organisation asked. “Why not the inspectors who had previously granted WHO GMP certification be held responsible for any type of anomalies observed?”
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