REGULATORY DOSE

Government proposes a new drugs policy that would give it greater control over medicine pricing

It seeks to provide boost to local industry and curtail the powers of National Pharmaceutical Pricing Authority.

The government has proposed dramatic changes to regulations that keep a check on prices of medicines and medical devices in order to prevent profiteering and deliver affordable healthcare to patients. The Department of Pharmaceuticals has drafted a new pharmaceutical policy that proposes to balance the need for price control over medicines with the Union government’s push for ease of business and “Make in India” programme – this time for the domestic pharmaceutical industry.

If the draft is accepted, the National Pharmaceutical Pricing Authority, which on Wednesday capped the prices of orthopedic knee implants bringing costs of the basic model down 65% from current market prices, will lose substantial powers and heft. In its place, the Union government will gain a greater role in deciding prices of medicines and medical devices. The likelihood of price caps being imposed on patented medicines will go down.

At the same time, the draft policy requires pharmaceutical manufacturers to sell their medicines under generic names and not under differently-priced brands. The policy also proposes that illegitimate promotion of medicines would attract legal action and will not be left to self-regulation by industry.

The policy also sets out a host of actions, schemes and changes in regulations to facilitate higher growth of the domestic pharmaceutical sector.

Scroll.in reviewed a copy of the draft policy which has been shared with select stakeholders for discussions.

Current price ceiling mechanism

At the moment, the pricing authority is required to function as an independent body of experts, largely protected from the Union government’s influence. The authority was constituted in 1997 and given these wide-ranging powers to regulate medicine prices in 2013.

The authority has the powers to fix the maximum price at which medicines and several medical devices can be sold to patients. These include medicines and devices that have been specifically listed by the Union government for price control. But, the authority also has discretion to put a cap on the price of any medicine or medical equipment under extraordinary circumstances for public interest.

The authority used its overriding powers on Wednesday to cap the prices of knee implants and earlier in February to bring down the prices of cardiac stents by 85% in pursuance of court directives. Even earlier, it has done so for many medicines as well. It has tried to use this power to also cap prices of patented medicines that do not fall under the government’s list of essential medicines. The authority’s website, updated last in 2016, notes that since 2015 it had fixed and notified the ceiling price of 330 medicine formulations by June 2016 and planned to set price caps for all 799 formulations that are listed in the national list of essential medicines.

The authority could now lose its teeth if the new pharma policy is accepted in its current shape.

Keeping pricing authority in check

The new draft pharmaceutical policy suggests that the authority regulate only those medicines and medical equipments that are specified by the government in the National List of Essential Medicines. It would lose the powers to invoke extraordinary circumstances to regulate other medicines and medical devices as it did on Wednesday and earlier in February.

The pricing authority will also lose the option to fix prices of patented medicines. Currently, the Drug Price Control Order is used to regulate the prices of all branded and generic medicines on the National List of Essential Medicines that contain the same molecule or active pharmaceutical ingredients. This does not include patented drugs but the authority has previously used its special powers to control their prices too in public interest.

The draft policy recommends that the prices of drugs still under patents be regulated mostly by compulsory licensing and the authority step in as an exception only when instructed by the government. Under compulsory licensing the patent holder allows another company to make a generic version of the drug at a forced low license fee. The Patents Act allows the government to grant compulsory licenses under circumstances of extreme emergency or in the case of public non-commercial use. The government has, so far, issued only one compulsory licence.

In 2016 the United States Trade Representative noted that the US India Business Council had been “privately assured” by the Indian government that it would not would not use compulsory licences for commercial purposes. Three other business associations also reported to the US government that India sounded more “positive” in its approach against compulsory licensing and in favour of protecting patents. In 2017, the US Trade Representative noted that India continued to be on its watch list and would be lobbied for stricter intellectual right protection laws, particularly for the pharmaceutical industry.

Prime Minister Narendra Modi addressing the US-Indian Business Council in September 2014. (Narendra Modi/Flickr)
Prime Minister Narendra Modi addressing the US-Indian Business Council in September 2014. (Narendra Modi/Flickr)

The European Union too advocates much better protection for intellectual property rights squeezing the space for countries such as India to undertake any large scale compulsory licensing of medicines. The draft policy also states that once the authority fixes prices, it would not be able to revise these prices unless directed specifically by the government or a higher court to do so.

The draft does clarify that the ceiling price of regulated medicines will be linked to changes in the wholesale price index.

What the new draft policy does not indicate is whether it will change it basic formula for fixing the prices of essential medicines and medical devices. At the moment the price cap is calculated on the basis of market prices of medicines being sold in the market. Earlier the cap was built on a cost plus model, in which the authority would calculate the costs incurred by the manufacturer and then put a cap above that to limit profits at all levels in the supply chain.

In 2013, the All India Drug Action Network, in an on-going public interest litigation, challenged the government’s decision to switch from a cost-based pricing formula to cap prices of essential medicines to a market-based pricing formula claiming the market-price based formula for deciding the cap resulted in a smaller reduction of drug prices.

Limited authority

The draft policy also wants to substantially alter the functioning and organisation of the National Pharmaceutical Pricing Authority.

The authority was envisaged as a body of independent experts consisting of a Chairperson with the rank of a secretary to the government. Additionally it was to have members with expertise in the field of pharmaceuticals, economics and cost accountancy and a member secretary. The authority’s website says it currently has an IAS officer as chairperson and a member secretary as full time officials. The Drugs Controller General, an economic advisor from the department of economic affairs and an advisor from the department of expenditure as other members.

If the policy is adopted, along with the chairman, the authority will have a member (enforcement) and a member (pricing), who will be selected by the government. Decisions of the authority will be made by consensus of these three members.

The authority will also have an advisory body that includes members of civil society, doctors, pharmacists, industry representatives and government representatives – all of whom will all be nominated by the government. While the advice of this body will be recommendatory, the authority will have to give reasons in writing for modifying or rejecting its advice.

The other staff of the authority can so far be hired by the authority under qualifications laid down by the government. Under the draft policy the government shall provide the necessary staff on deputation and no one shall serve more than three years in the authority.

Unlike present practice, appeals against the orders of the authority shall lie directly with the Union government. The union government’s decisions can be challenged in court.

Quality control and ease of business

The new policy also states that the list of for capping prices – the Drug Price Control Order – will have only the medicine’s name. So far this list includes strengths and dosages of medicines as well, which allows pharmaceutical companies to make minor adjustments to the strength of the drug and market it as a “new drug” outside price control. By mentioning only the drug name, all strengths and dosages of the medicine will fall under the price cap.

A major change that the draft policy suggests is the use of only salt (active ingredient) names on the packaging of generic drugs. Branded generic drugs are currently sold like other patented medicines, with their brand names displayed on the packaging. A manufacturer, the policy states, will only be allowed to stamp the company name and the generic name on drug packaging and not a brand name. Patented drugs and fixed dose combinations can be sold under brand names but the Department of Pharmaceuticals will have to ensure only that a company offers a drug with the same active ingredient under only one brand name and with one price.

The policy also seeks to bring down the unreasonable trade margins offered by various stockists to hospitals.

An enabling legal environment will be created to set up bulk drug and pharmaceutical parks in private-public partnerships with ease of clearances and common facilities such as common effluent treatment plants being set up by the central government for the industry. While the policy makes bio-availability and bio-equivalence tests mandatory for quality control a prerequisite to get manufacturing licences from state and central drug regulators, it also allows manufacturers to self certify that their products are compliant with these tests until their licences come up for renewal. The Central Drugs Standard Control Organisation is to conduct annual audits of drug companies’ manufacturing facilities, but the policy suggests that even these facilities may be self-certified until the regulator sets up an adequate inspection mechanism. The government shall ensure to get the World Health Organisation’s Good Manufacturing Practices and Good Laboratory Practices adopted by all manufacturing units in a phased manner. Central and state drug regulators will have to give manufacturers clearances within a period of three months – extendable by another three months at best.

The draft policy also seeks to legitimise and encourage online sale of medicines under guidelines that have “adequate safeguards”, stating that opportunities in the e-pharmacy sector hold potential for attracting Foreign Direct Investment.

Support our journalism by subscribing to Scroll+ here. We welcome your comments at letters@scroll.in.
Sponsored Content BY 

Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

Play

This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.