India has come up with Medical Devices Rules, 2017



CDSCO has published the Medical Devices Rules 2017.

This Rule has been published in the Gazette of India Extraordinary on 31 Jan 2017.
The Rules are very explicitly explains the requirements from various stake holders and balanced in managing the expectations of stake holders and also the Regulatory agency.

Please find below the link to the Medical Device Rules, 2017.

Medical Device Rule gsr78E

New FDA Drug Approvals: Breaking Down the Numbers

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst, the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved.

2016 approvals

But as John Jenkins, director of FDA’s Office of New Drugs, who’s retiring from FDA on 7 January, wrote on Wednesday (and explained in November), the lower number may not be a clear signal that industry innovation is stalling.

Jenkins wrote: “For example, CDER approved five novel drugs in 2015 that had PDUFA goal dates in 2016. These early approvals benefited patients by making the drugs available sooner, but also decreased the total of novel drugs approved in 2016. Another factor was the number of Complete Responses (CR), which describe deficiencies in the application, precluding approval, with advice on what the sponsor needs to do for FDA to support resubmission of the application. CDER issued 14 CR letters for novel drugs in 2016, higher than in recent years.”

Jenkins also notes that the primary deficiency in several of the applications was the failure to comply with FDA’s current Good Manufacturing Practice (cGMPs) regulation, whereas by comparison, only four of the 47 new drug applications issued a CR from 2010 through 2015 included a failure to comply with cGMPs as the primary deficiency.

“2016 may serve as a reminder to sponsors that all of their manufacturing facilities must be in compliance with cGMP regulations if they wish to ensure approval of their application. Failure of manufacturing facilities to pass FDA inspection can unnecessarily delay patient access to novel new drugs,” Jenkins added.

Numbers Breakdown

Of the new drugs approved in 2016, the majority (like in previous years) benefited from at least one of FDA’s programs to speed up a drug’s development or expedite a review.

Eight of 22 approvals (36%) in 2016 benefitted from a fast track designation (meaning they had the potential to address unmet needs), seven (32%) were considered breakthrough therapies (meaning that preliminary clinical evidence demonstrated substantial improvement over other therapies), 15 (68%) received a priority review designation (meaning a six-month review period instead of the standard 10 months), six (27%) received accelerated approval (meaning early approval for a serious or life-threatening illness with benefit over existing therapies).

Those numbers are similar to what occurred in 2015, when 14 of the 45 approvals (31%) came via the fast track designation, while 10 (22%) were so-called breakthrough therapies, 24 (53%) were priority review drugs and six of the drugs (13%) were approved under the accelerated approval program.

And for those still claiming that FDA does not approve drugs faster than other countries: 19 of the 22 novel drugs approved in 2016 (86%) were approved in the US before any other country, which is similar to what occurred in 2015, when 29 of 45 approvals (64%) occurred first in the US.


Report: Global drug market will hit $1.5T in 2021

Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, even as annual growth moderates from the record pace set in 2014 and 2015, according to new research released by the QuintilesIMS Institute. While historically large numbers of high-quality new medicines will emerge from the R&D pipeline in the next five years, pricing and market access pressures, lower volume growth in pharmerging markets and greater savings from patent expiries will contribute to the lower rate of growth.

The report, Outlook for Global Medicines Through 2021: Balancing Cost and Value, found that medicine spending will grow at a 4-7% compound annual rate during the next five years, down from the nearly 9% growth level seen in 2014 and 2015. The total global spend for pharmaceuticals through 2021 will increase by $367 billion on a constant-dollar basis. Spending is measured at the ex-manufacturer level before adjusting for rebates, discounts, taxes and other adjustments that affect net sales received by manufacturers. The impact of these factors is estimated to reduce growth by $127 billion, or approximately 35 percent of the growth forecast through 2021.

“The outlook for medicine spending growth reflects a more sustainable level for health systems, following the unexpectedly high growth seen in recent years,” said Murray Aitken, senior vice president and executive director of the QuintilesIMS Institute. “At the same time, the astonishing level of scientific advances for disease treatments inevitably will place ongoing pressure on funding for medicines—requiring value-based assessments that balance patient needs and pricing levels with competing healthcare priorities.”

In its latest study, the QuintilesIMS Institute highlights the following findings:

  • Global medicine spending will reach nearly $1.5 trillion through 2021 on an invoice price basis, rising 4-7% CAGR. Growth in spending will slow from nearly 9 percent in 2014 and 2015—a growth rate driven in part by new hepatitis and cancer medicines that will have less impact through 2021. Most global spending growth, particularly in developed markets, will be fueled by significant innovations in oncology, autoimmune and diabetes treatments. The U.S. will continue as the world’s largest pharmaceutical market, contributing 53% of forecasted growth over the next five years, while China will continue as the second largest market contributing 12% of the growth.
  • New drug launches will reach historically high levels in the next five years. More than 2,000 drugs in the late-stage pipeline will yield an expected 45 new active substances (NAS) on average annually through 2021. The new medicines will address significant unmet needs across a wide range of disease areas, including cancer and autoimmune, metabolic and nervous system disorders. The sheer number of cancer treatments, their potential combinations in treatment regimens and the variety of companies involved in development will bring significant complexity to the patient care landscape during the next five years. Dramatic improvements in survival and tolerability are expected and will be accompanied by substantially greater levels of clinical trial and real-world information in support of treatment decisions.
  • Single-digit spending growth is forecast for the U.S. market. The U.S. market growth rate will decline by half, from 12% in 2015 to 6-7% this year, with 6-9% growth forecast through 2021 on an invoice price basis. The decline reflects the end of Hepatitis C treatment-driven growth and greater impact of patent expiries—including the introduction of biosimilars—following a period in which fewer brands faced new generic competition. U.S. growth in 2014 and 2015 also was driven by historically high price increases for both brand drugs and generics on an invoice-price basis before the impact of off-invoice discounts and rebates. After adjusting for price concessions by manufacturers, spending growth is estimated to be more than 2 percentage points lower through 2021 and 4 percentage points lower in 2016—a 4-7% CAGR on a net-price basis.
  • European payers are expected to maintain tight constraints on drug budgets. Forecasted low pre-rebate and discount growth of 1-4% in the EU5 countries through 2021 reflects policymaker responses to unexpectedly high new drug spending in 2014 and 2015, and relatively weak economic growth in the region. The Hepatitis C drugs were surprising to stakeholders in their effectiveness, the extent to which patients and providers were willing to use them, and the budget impact that few were able to accurately predict. Looking forward, these budgeting weaknesses are expected to prompt European payers to redouble their efforts to bring predictability to their budgeting processes for drugs. The impact of BREXIT on the U.K. pharmaceutical market is expected to be modest, driving at most a 1.5% slower growth rate.
  • Lower economic growth triggers slower expansion for medicine use in pharmerging markets. Leading pharmerging markets have seen real GDP growth slow from 1-4 percentage points over the past decade. This has triggered a corresponding reduction in medicine volume growth, from an average of 7% annually over the past five years to 4% forecast through 2021. China, in particular, will see a decline in annual volume growth from 17% to 4% over the same period. Overall, volume growth continues to be driven by non-original products that account for 91% of the volume in pharmerging markets. The outlook for spending growth across these markets is expected to moderate from 10% CAGR over the past five years to 6-9% through 2021.

Minutes of 74th Meeting of Drugs Technical Advisory Board

CDSCO has shared the minutes of 74th meeting of Drugs Technical Advisory Board Held on 15th nov 2016 at DGHS, Norman Bhawan, New-Delhi

Important point which was discussed in the meeting pertaining to Clinical Trials are

  • it was recommended that DTAB should be informed about the status of its recommendations for any amendments in the rules, as to whether the recommendations of the DTAB are being considered for framing suitable rules or not, within a period of thirty working days from the date of finalization of the minutes of DTAB.
  • the Ministry may be requested to depute one of his senior officers for participating in the meeting of the DTAB, so that recommendations can be made considering the views of the Ministry.



Pharma research approval system to be put on fast track

NEW DELHI: The BJP-led NDA government will set up a single window approval system that will clear in 30 days what four different committees took 3-4 years in a major boost to innovation in medical research and will help improve India’s sagging reputation in the area of ease of doing business. 

The government think-tank Niti Aayog has written to Health Ministry to restructure the entire approval process for innovation in medical research as part of the government’s move to make India a hub for innovation and manufacturing. 

“There is a need to encourage and support innovators on approval procedures and regulatory requirements. I would appreciate your convening a meeting and restructuring the entire approval process,” said Niti Aayog in a letter written by CEO Amitabh Kant. 

Kant could not be reached out for comments. 

The Aayog’s proposal has got support from the committee of secretaries set up on the prodding from the PMO to overhaul the pharmaceuticals sector in the country. The committee, comprising Kant, pharmaceutical secretary Jai Priye Prakash, health secretary CK Mishra and DIPP secretary Ramesh Abhishek, in a meeting last month decided to carry out a complete business process re-engineering of new drugs and clinical trial. 

According to the letter addressed to health secretary CK Mishra, copy of which is available with ET, the Aayog suggested half-a-dozen measures to reengineer business process for government in a way that it encourages innovation in medical research. 

“Permission/approvals within 30 days from the date of application for Indian Innovation projects who have applied for global patent. Failing to process application within 30 days, it will be presumed as approved like in USA,” Kant’s letter said. 


The Aayog has also proposed establishing of a single window system of application to get approvals from various agencies, abolishment of role of the Review Committee on Genetic Manipulation (RCGM) at R&D stage and strengthening of the Institutional Biosafety Committee. 

“Top priority should be given by various agencies for any innovative product developed in India, age old procedures need to be re-examined to encourage innovation in India and pre-approval meetings with various agencies should be considered to understand their requirement and plan for roadmap for getting approvals,” the letter proposed.


CDSCO has come up with the list of NABL accredited NABL certified Laboratory

CDSCO has come up with the list of NABL accredited laboratory in India which is good for the Pharma companies and CRO who are conducting clinical studies in India. This step of CDSCO has been welcomed by Pharma and CRO companies.

Along with the list of lab CDSCO has also come up with the list of certified Drug Manufacturing Units in India.


Govt Consults Top Foreign Regulators to Rewrite Drug Laws

Finally junking the 75-year-old Drug and Cosmetics Act, the health ministry is consulting top drug regulation bodies worldwide in order to write a new laws for drugs.

Until last year, the government is trying to tweak its archaic Drugs and Cosmetics Act 1940 with an amendment bill being introduced in the Rajya Sabha in 2013. However govt withdrew the amendment plan in June. 

“The primary Objective of the new law would be to push Make in India, allow better regulation of the latest generation of treatments, boost the quality of domestic manufacturing and improve oversight of clinical trials,”said G.N.Singh Drug controller General of India.

“We will consult almost every health regulator who deals with made-in-India medicines, starting with FDA of the US, the MHRA of UK and the European Medicines Agency.”

The D&C Act labelled as a “law of bygone era”can’t cater to the modern day requirements. We need laws for the online sales of medicines, separate rules for medial devices, latest compliance methodology and competitive good manufacturing practices.

“We have also drafted a new set of Good Manufacturing Practices which are on a par with GMPs drafted by the World Health Organization. the idea is to convince global regulators and domestic consumers about the efficacy of our medicines,”Singh said


GOI forwarded Proposal to waive Phase III clinical studies

The country’s drug controller is planning to waive local clinical trial of drugs meant to treat certain type of cancer, AIDS, hepatitis and rare blood disorders if the drugs are cleared in “well-regulated” countries like the US, Australia, Canada, Europe and Japan.

This will lead to quick availability of several drugs needed to cure life-threatening ailments and rare diseases, said Drug Controller General of India (DCGI) GN Singh, adding a proposal in this regard has been forwarded to the Health Ministry for its approval.

However, such drugs will be subject to strict post-marketing surveillance for four to six years to look into their safety and efficacy.

The decision is in keeping with the recommendation of Prof Ranjit Roy Chaudhury committee report, which said, “The waiver of clinical trial on Indian population for approval of new drugs, which have already been approved outside India, can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy”.

Singh said that the Drug Technical Advisory Board (DTAB), the Government’s highest decision-making body in respect of drug clearance, at its last meeting agreed that clinical trials for a certain segment of drugs will now be done “only if required”. The Drug and Cosmetic Act, so far, does not allow any drug to enter domestic markets for sale unless these have cleared three phases of clinical trials pre-approval.

“As phase III clinical trials on a drug is a long process, usually taking up around two years, we don’t want the patients to suffer,” said the drug controller, adding  that the waiver would also require drug sponsors “to agree to implement a four-year post-marketing surveillance plan, which would need to be approved by us”.

“This is to ensure the drug quality and its efficacy,” added Singh.

The drug controller said that since the clinical trials are undertaken in developed countries under strict vigilance and safety, there is no question of raising safety issues in such drugs.

Though earlier also the Government had been approving drugs falling in such categories, the issue was relooked again after Parliamentary Standing Committee in its 59th report had raised concerns on approval of certain new drugs in the country without local clinical trials.

In its proposal to the health Ministry, the DCGI observes that conducting local clinical trial with new drugs indicated for serious/life threatening diseases like cancer and AIDS which are already approved in other country will delay its introduction as well as increase the cost for the patients in case no satisfactory alternative therapy exists.

As per Chennai-based Foundation for Research on Rare Diseases and Disorders, it is generally accepted that a disease having fewer than 100 patients per 100,000 population is described as rare disease and fewer than 2 patients per 100,000 is described as ultra rare disease. Ultra rare diseases are rarest of rare diseases. Rare and ultra rare diseases are sometimes referred to as orphan and ultra orphan diseases, respectively.

There around 72 crore patients in India suffering from rare diseases with most common being Haemophilia, Thalassemia, Sickle-cell Anaemia and Primary Immuno Deficiency in children, auto-immune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and certain forms of muscular dystrophies.  

Government looks to fast-track approvals for clinical trials

As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.  

The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.  

This comes two months after the drug regulatory agency eased rules related to clinical research — a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee and could risk patient lives, groups like Swasthya Adhikaar Manch earlier told ET.  

“(There will be) changes to the (regulations) to make it both easy and stringent,” a senior health ministry official told ET, speaking about the government’s upcoming move on the condition of anonymity.  

According to the official, the changes include a reduction in processing and approval time for clinical trials here while ensuring that companies adhere to higher quality standards.  

The government has so far halved the clinical trial processing and approval timeline which previously would, in some cases, take up to a year and half, said the official. “The target is to reduce (the entire process) further by 30-40%.” Clinical trial regulations will also be tightened on quality parameters, focusing on aspects like the profile of the recruited patients and the CROs enrolling them, said the official. For this purpose, CROs across the country will be inspected for compliance with Good Clinical Practice (GCP) standards, the official added. 

The government has reduced the timeline by measures like increasing the frequency of meetings of the committees granting the approvals and waivers, said another senior ministry official who also preferred to remain anonymous. The Subject Expert Committee, for instance, now meets once a month as compared to once every three months.  

It has also introduced an online system to receive and process clinical trial applications faster. 


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