An MP Hands Out Bitter Pill to Pharma Cos

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Economic Times, August 10, 2012

A doctor by vocation, Jyoti Mirdha gives pharmaceutical firms a difficult time .

If pharmaceutical companies and drug regulators in India have been lately facing scrutiny in greater and vicious doses, some of it can be traced to the dogged inquisitions of a young, first-time parliamentarian: Jyoti Mirdha. This Congress MP is one of the 31 members in a parliamentary committee that voluntarily examines healthcare issues, but she is making her presence felt with her proactive work and, some say, her anti-industry policy positions.

Sample this. In July, about a month after Mirdha wrote to the prime minister, the government pulled out of cold storage a code of conduct for companies on dealings with doctors and promised to notify it in August.

Earlier, in May, she made a presentation to the group of ministers (GoM) on the new drug pricing policy, making a case to bring all drugs under price regulation. That same month, the parliamentary committee, based on a report by a sub-committee of which she was the convenor, alleged lapses and corruption in the process of drug approvals, shaming several frontline companies and hauling up the lead drug regulator. ?She is the driving force behind the report,? says Ramesh Adige, the former head of regulatory affairs at Ranbaxy Laboratories.

For all the attention her work is drawing, the Lok Sabha MP from Nagaur in Rajasthan is reluctant to talk about it, or herself. ?…if you dig slightly deeper, you?ll know I don?t interview!? she initially emailed ET in response to a request for an interview. She later relented, but only to clarify her stand on issues raised by her.

What is known about Mirdha is that she is the grand-daughter of late Nathuram Mirdha, a veteran politician. Her profile page on the Lok Sabha website shows that Mirdha graduated as a doctor from SMS Medical College, Jaipur, and lists her ?special interests? as ?water resources, alternative medicine (especially nutrition) & renewable energy?. The medical education appears to be holding her in good stead today as she is voicing her opinion on a range of issues relating to the pharma industry, including drug pricing, clinical trials, acquisitions by foreign companies and marketing practices.

Describing her as ?passionate and sincere?, Dr Sanjay Jaiswal, another committee member and BJP MP, says: ?She is well-prepared, with loads of information.? Adds Lalit Kumar Jain, a lobbyist for small drug manufacturers: ?She is also close to some NGOs and drug regulatory experts who are working in public interest. They provide her all the requisite information.?

Keeping Distance from Drug Cos

Mirdha is also seen to keep a distance from pharma companies. ?She has no conflict of interest,? says Jaiswal, adding that she has, at times, even asked committee members to abstain from discussion on issues where they had a business interest.

At least three of Mirdha?s policy positions have riled industry players: controls on pricing of all drugs; mandatory rules and penalties to govern the company-doctor relationship; and controls over foreign investment in Indian companies. ?When policies are made, you should look at the welfare of 120 crore people, and not that of a few individuals or companies to further their limited interest,? she says. ?I?m all for industry if it means productivity, enterprise and innovation. But if it means exploitation or extortion, then you could label me anti-industry.?

Mirdha feels prices of all drugs should be regulated, not just those based on 74 ingredients (out of 900-odd), as is the case now. ?A cost-based mechanism is the only effective way to regulate prices of drugs,? she told ET in May. ?Companies have been found to be selling at multiple times the cost price and market-based pricing would further support it.?

When the department of pharmaceuticals put out a draft of the drug pricing policy and invited public comments, she was the sole MP to respond, resulting in the GoM on drug pricing inviting her to make a representation. Mirdha made a 29-slide presentation to the GoM, the central idea of which was to bring all drugs under price regulation, something the industry is strongly opposed to.

On her own initiative, Mirdha has been also pursuing to give more teeth to rules on drug marketing, the proposed form of which is self-regulatory. In this regard, she has written two strongly-worded letters to the prime minister.

The first one was in June 2011, where she made a case against self-regulation while slamming the establishment. ?It is strange that despite irrefutable evidence, the department of pharmaceuticals is pushing for a voluntary code,? she wrote.

In the second letter, this June, she attached documentary evidence of a pharma company paying for an eight-day holiday for 11 doctors and their families to England and Scotland. She, once again, urged the government to change the spirit of the rules from voluntary to mandatory, and put down penalties and enforce them. ?The pharma market is an aberration in a free-market economy,? she says. ?In a free market, there are multiple players competing to gain market share through quality and pricing. The consumer then makes a choice. Only in pharmaceuticals, however, the consumer is the doctor, who decides which brand to be bought by the patient.? ?She has a limited understanding on the workings of the pharmaceutical industry,? says an official of a private equity firm that has investments in pharma companies. ?How do you then promote your medicines?? Adds DG Shah, secretarygeneral of the Indian Pharmaceutical Alliance, a grouping of large Indian pharma companies: ?These are legacy issues that need to be sensibly tackled using a longterm approach, with effort from both companies and doctors. Nothing can be changed overnight.?

Another issue of divergence between Mirdha and drug manufacturers, mostly foreign, is foreign direct investment (FDI) in pharma companies. Mirdha has been railing against the spate of acquisitions of Indian generic companies by foreign majors. In October 2010, Mirdha wrote to the finance ministry seeking a cap on FDI in pharma. ?If in due course, most, if not all, domestic manufacturers capable of producing high-technology medicinal raw materials and formulations are taken over by MNCs, then all safety nets (such as compulsory licences, opposition to grant of patents, patent challenges abroad, Drug Price Control Order, laws against abuse of dominant position, etc) will be rendered ineffective,? she wrote. Although the government has not capped FDI, in July, it changed the automatic-approval policy for such acquisitions and introduced riders. While these are submissions in her personal capacity, as part of the parliamentary panel, Mirdha?s most notable work has been on the alleged corruption in processes for drug clearances. Speaking on the condition of anonymity, two officials from drug regulatory bodies and regulatory heads of two prominent pharma companies compliment her forthright and activist approach. ?It is needed to straighten a few things,? one said.

The office of one of those government officials has been at the receiving end of criticism from the parliamentary panel Mirdha is part of. ?She knows her job well. She was well-prepared, with all information, and asked specific queries,? he says of his interaction with Mirdha.

While describing her as ?aggressive and rigid?, Jaiswal feels she is wrongly perceived to be anti-industry. ?Economic productivity links up to the health industry through ?cost of health?,? she says. ?The higher the cost of health, the lower will be national productivity. Now, I ask you: am I arguing for capitalism or against it?? Adds Adige: ?She is not one to give up.?

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