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CDSCO’s move to curb Oxytocin misuse leaves industry fuming
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Arun Sreenivasan, New Delhi
March 06 , 2018
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The Central Drugs Standard Control Organisation (CDSCO), after a crucial
meeting on February 22 with manufacturers and industry representatives,
has mooted tougher regulations to check import and distribution of
Oxytocin, a neurotransmitter and peptide hormone, which is widely
misused in dairy and horticulture industry.
According to a
circular issued on February 28 by newly appointed Drugs Controller
General of India Dr S Eswara Reddy to industry associations and other
stakeholders, the proposals being weighed by the government include
prohibiting the import of Oxytocin and its formulations for human as
well as animal use under section 10A of the Drugs and Cosmetics Act and
regulating and restricting it under Section 26A of the Act.
The
government also wants to restrict its manufacturing to public sector
Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) in Bengaluru. If
the proposals materialise, HLL Lifecare will be the sole distributor of
the drug in the country. Another measure in the pipeline is a bar-coding
system for Oxytocin formulations to ensure traceability. The proposals
are not applicable to Oxytocin meant for export. The DCGI’s letter
requests all stakeholders to submit their feedback within 15 days.
While
welcoming the steps to increase traceability and control illegal
imports of Oxytocin, Federation of Pharma Entrepreneurs (FOPE) President
BR Sikri strongly opposed the move to restrict its manufacturing to
PSUs. “This drug’s beneficial medical uses are well known. It is
available in the country in various brand names and has a market worth Rs.50-60
crore. Its misuse should be tackled, but banning production in the
private sector is not the way to do it. How is it possible for one PSU
manufacturer and distributor to supply the product all over the country?
This wonder drug will be in short supply if the government implements
the Drug Technical Advisory Board’s recommendations,” Sikri, who
attended the key meeting with CDSCO officials, told Pharmabiz.
Oxytocin
causes uterine contractions thereby inducing labour naturally and
controls post-delivery bleeding. But it is misused in the dairy industry
where livestock are injected with it to make them release milk at a
convenient time. Many farmers use it to plump up vegetables. Studies
have proved that its sustained use can cause hormonal imbalance in
humans and ruin the reproductive system of animals, cutting their life
span substantially.
Following last week’s meeting with CDSCO
experts, FOPE has written a letter to the ministry of health to put
forth the viewpoint of the industry and propose suggestions to stop the
misuse of the drug. In the letter, reviewed by Pharmabiz, the federation
pitches for checks and balances to tighten the drug supply chain.
“One
reason for blatant misuse is the absence of robust veterinary policies
and treatment guidelines. Novel drug delivery systems should be explored
in the dairy sector. But this will take time and needs the support of
government agencies,” FOPE president pointed out. According to sources,
the CSDSCO wants to implement restrictions in a month’s time. Industry
stakeholders unanimously object to this move. “A formulator normally
keeps raw material and packaging items for three months. Some stock will
be in the market and some in the pipeline. A sudden production halt
will take a heavy toll on the manufacturer and leads to drug shortage,” a
drug company executive opined.
The ready availability of
Oxytocin is high-priority for a country like India where, as per a WHO
report, five women die every hour from complications developed during
childbirth with heavy blood loss caused by haemorrhage being a major
factor.“The government should think twice before banking on a single PSU
for the production of an indispensable drug. The lack of Oxytocin in
the armamentarium of gynaecologists would put lives of many pregnant
women at risk,” a healthcare professional added.
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