The healthcare imperatives in India, as well as the resulting laws and regulations governing health, are unparalleled anywhere else in the world. In the absence of a large reimbursement or insurance system, successive Indian administrations have concentrated their efforts on obtaining significant reductions in out-of-pocket expenditure on healthcare and medications.

Currently, there is no such system in existence. Since 2014, drug prices and access to affordable healthcare have played a significant role in campaign rhetoric in both general and state elections. The issue of affordable healthcare, as well as the disproportionate emphasis placed on the prices of pharmaceuticals and equipment, has been taking up more and more space in the political and media arenas in recent years.

The current government is proposing significant changes to the legal and regulatory framework after increasing the scope of price regulation for medications and medical devices that have been notified as drugs (e.g., stents and orthopedic knee implants).

You can also visit API First to know more about the recent changes in the pharma regulation laws.

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Pharma Pricing

Prices in India have been controlled in some way or another since the early 1970s. It is mandated under the Essential Commodities Act of 1955 that a Drug Price Control Order (DPCO) be issued, and all pharmaceuticals included on the National List of Essential Medicines (NLEM) are subject to the DPCO. Currently, there are 3762 pharmaceuticals in NLEM 2015, which includes a handful of copyrighted drugs as well as some unpatented medications.

In India, price limitations on medications, which are frequently arbitrary and unexpected, have presented a significant obstacle to the pharmaceutical industry’s ability to conduct business successfully in the country. Price reductions that are irrational and excessively severe have acted as a de facto trade barrier for companies doing business in India.

When it comes to medical device price controls, the Indian government has recently broadened the scope of arbitrary price controls that were previously restricted to the pharmaceutical industry. These measures are significantly more stringent and devoid of rationale when compared to the previous restrictions on drugs.

Pharma Generic Prescriptions

In April 2017, Prime Minister Narendra Modi declared that the government would build a legislative framework that would require doctors to prescribe medications only by their International Non-proprietary Names (INN) rather than their generic names.According to the Prime Minister, it is only through this initiative that underprivileged people will be able to obtain low-cost medications.

Moreover, the Indian Medical Council (Professional Conduct, Etiquette, and Ethics)Regulations, 2002 had already been changed in 2016 to require that medications be prescribed by generic names only by registered medical practitioners, which was a source of confusion. However, in order to accelerate the transition to a generic market, the government has implemented a number of tools for the promotion of generic pharmaceuticals, including revisions to drug regulations.

Pharma Regulatory Changes

For two years, CDSCO has been working on streamlining the regulatory process by relaxing, rationalizing, and amending current rules of the DCR. This has resulted in the approval of medical devices being hastened without sacrificing their quality, safety, or performance.

Planning is underway for a new set of simplified and comprehensive New Drugs and Clinical Trials (CT) Rules to be promulgated under the Drugs and Cosmetics Act (DCA), which will codify all revisions to the Act that have occurred to date. As part of its efforts toward digitalization and the implementation of the e-governance scheme, the Ministry of Health (MoH) introduced its online licensing system, known as SUGAM, which is being gradually developed on a constant basis.

Pharma Medical Device Rules

As part of this effort, the government is streamlining the medical device industry, which has undergone a paradigm shift this year with the notification of separate and distinct Medical Devices Rules (MDR), 2017, which will become effective in January 2018 and replace the existing Medical Devices Rules, 2017. As a result of being notified as “drugs” (as defined in the DCA) in phases, the MDR aims to bring the entire universe of devices into the ambit of CDSCO, the drug regulator, and hence under its supervision.

According to Section 3(b)(iv) of the DCA, only 22 types of medical devices are now regulated as “drugs” in India, and all other non-notified medical devices do not need a registration certificate or any other regulatory clearance.Regulatory approval would be necessary in connection with the MDR and the subsequent notification of medical devices under its provisions.

Enforcing One Company, One Drug, One Molecule

During the 50th meeting of the Drug Consultative Committee, which was held on November 4, 2016, it was first brought up the problem of the sale of the same drug under many brand names and at various price points. There have been concerns raised about the availability of many brands of the same drug (produced by one business and promoted by multiple companies) at varying price points.

According to the recommendations, a separate committee should be established to develop recommendations for measures to prevent the misapplication of current practice in the area of third-party drug manufacturing, which occurs when a product manufactured by one company is marketed by multiple companies.

A restriction on the use of several brand names is proposed in the current draught NPP, as is the implementation of the idea of “one manufacturer, one salt, a single brand name, and a single price.” In addition, the draught NPP wants to restrict third-party manufacture, which is commonly used by firms to produce brand variations of the same composition under different names.

Pharma Marketing Code

Undoubtedly, the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which is being pushed forward by the Department of Pharmaceuticals (DoP), is a remarkable piece of legislation. The UCPMP was implemented as a voluntary code on January 1, 2015, and became effective on that date.

Gifts, hospitality, and travel, which the industry is believed to provide to doctors, are addressed in the Code, which also includes regulations on claims and comparisons, textual and audio-visual promotional material, the behaviour of sales people, and the samples that they provide to doctors. It is now being considered by the Department of Agriculture for inclusion in the Essential Commodities Act, 1955, as well as the imposition of penalties on enterprises that violate the Code of Conduct.

The Bottom Line

So, as you can see that the Indian Government has set some strict pharma regulations which you should adhere to if you are planning to open a business in the pharmacy sector. So, we would suggest you to visit API First – Pharma Regulatory consultants and group of experts. They have a vast knowledge on the new regulations and would assuredly help you in getting certified.

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