No plan for mandatory pharma code, says govt

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NEW DELHI: For over four years the government has been maintaining that it was drafting a mandatory code on ethical marketing of pharmaceuticals with penal provisions since the voluntary code had not worked. But it has now admitted in Parliament that it has no intention of making the code mandatory.
On September 18, when chemicals minister DV Sadananda Gowda was asked if the government had decided to make the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) mandatory, he said no. This is a u-turn from the government reply in the Lok Sabha on May 15, 2016 when it said: “…code was reviewed and it was now decided to make it statutory. Once the code is made statutory it is expected that the unethical practices could be controlled more effectively.”
Again, on June 2016, in Rajya Sabha, then minister Ananth Kumar, while answering a question about nexus between companies, hospitals and doctors to overcharge patients for medicines, admitted that the voluntary code introduced the previous year was not working well and added that the government was considering making it compulsory.
However, in his reply in the Rajya Sabha on Sep 18, the current minister when asked if the implementation of the voluntary code had not shown any results, the minister said that the UCPMP being voluntary, there was no provision for the Department of Pharmaceuticals (DoP) to directly deal with complaints about unethical practices.

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This is a strange flip-flop. The government seems to have taken four years to decide that it can do nothing. Since there is no evidence to suggest that its earlier conclusion that the voluntary code hasn’t worked was wrong, the rethink can only mean that the government lacked the will to create the code it had promised.

The minister further stated that as per the voluntary code, any complaint received against a pharma company was to be handled by an ethical committee for pharma marketing practices to be constituted in each pharmaceutical association. He added that the DoP was following up with the associations to implement the code effectively.
However, the minutes of a meeting held by the DoP secretary on August 21 with pharma and medical devices associations recorded a FICCI representative pointing out that associations could “only do naming and shaming and suspend or expel the offender company from the association” and that “the company would remain in the market”. The FICCI representative suggested that the redressal council in one of the associations ought to have the authority to take away the licence of the offending company.
Interestingly, the National Pharmaceutical Pricing Authority (NPPA), tasked by the DOP to oversee UCPMP implementation, in response to a Right to Information (RTI) application conceded in its reply on September 7 that it is neither mandated nor authorised to monitor pharma marketing practices. This admission from the NPPA came just a few days after it instructed pharma associations and companies on August 26 to submit quarterly reports on the implementation of the code to its office.
“It is sheer absurdity that the government is trying to monitor the implementation of the UCPMP, which is a self-regulatory mechanism of the pharma industry. The DOP secretary has admitted that under the UCPMP, action against companies can only be taken by pharma associations. In essence there is no role for the government in enforcement. Yet an eyewash exercise is underway to make pharma associations submit quarterly reports to the NPPA,” said Malini Aisola of All India Drug Action Network (AIDAN).
“The icing on the cake is the government’s reply in Parliament stating that it has no plans to make the UCPMP mandatory. We have been pressing for a legal instrument to replace the voluntary code and submitted evidence of unethical practices. Yet, DOP has not held a single consultation with civil society on this in the last two years,” pointed out Aisola.



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