Central Drugs Standard Control Organisation
The Union health ministry is all set to commence drafting of Drugs and Cosmetics (Amendment) Bill to amend the Drugs and Cosmetics Act, 1940 for upgradation and introduction of provision for newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trials after the Budget.
This would be in step with the central government’s ‘Make in India’ initiative. The move was welcomed by Organisation of Pharmaceutical Producers of India (OPPI).
According to a senior health ministry official, the work on draft of Drugs and Cosmetics (Amendment) Bill will begin after the Union Budget which is scheduled for February 1. The Bill proposed to cover new areas of biological, stem cells and regenerative medicines, clinical trials as well as compliance to regulatory issues. We are coming up with separate legislations for regulating medical devices and drugs and cosmetics. A set of draft rules for medical devices was prepared by the ministry and released last year. The Medical Device Regulations will be issued within a week, he added.
The Bill aimed at strengthening regulatory mechanism to ensure delivery of safe and quality medicines and facilitating ease of doing business in India will be finalized with consultation of all stakeholders including pharma industries, patient groups etc. Meanwhile we are revising regulations pertaining to new drugs, clinical trials, cosmetics to meet our current challenges and regulatory compliance requirement by amending the existing Drugs and Cosmetics Rules, the official added.
In June 2016 the government had withdrawn the Drugs and Cosmetics (Amendment) Bill, 2013 as it believed that would not be appropriate to make further amendments in the existing Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial or investigation cannot be effectively regulated under the present law. The Bill had been introduced in the Rajya Sabha. A Standing Committee of Parliament had made a number of recommendations for changing the provisions of the Bill.
Meanwhile, the OPPI has welcomed the decision of the government to revisit the Drugs & Cosmetics Act & the Rules. Amendment of the 1940 legislation would undoubtedly ensure delivery of safe and quality medicines and at the same time facilitate ease of doing business in India.
Given the dynamic nature of law as well as continuous advancement in science, importance of updated, effective, and streamlined drug regulations becomes paramount. OPPI believes that amendment in the existing regulations would certainly help remove ambiguities, augment research and innovation in India which, in turn, will enable bringing in new medicines to save and improve the lives of Indian patients.
“OPPI is appreciative of the fact that the Committees constituted by the Government to look into various aspects of law such as new drugs, clinical trials, manufacture etc. are engaging with stakeholders in the evolutionary process. OPPI looks forward to a continued engagement with the government in its endeavour to establish a transparent, process-driven and standardised regulatory structure,” said Kanchana TK, Director General, OPPI.
The Drug Technical Advisory Board (DTAB)’s move to approve change of name of the ‘Central Drugs Standards Control Organisation (CDSCO)’ to ‘Indian Drug Administration (IDA)’ will now mandate a dedicated pool of qualified workforce to man regulatory system. This will take India on a global platform like that of US FDA and EMA, said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO.
Following the 75th meeting of DTAB held on January 3, 2017, the Board’s approval to rename ‘CDSCO’ as ‘IDA’ to make it simple and befitting to its activities is the best that could happen to India’s regulatory office, he added.
During 2014, it was Dr Jagashetty in his role as the National Advisor who pressed for the CDSCO to be transformed with a name change to IDA and be given a different identity for an immediate recognition as an Indian Regulatory Authority across the globe. “Now the IDA will lay the foundation for qualified pharmacy professionals and this will automatically spur rapid license approvals in a transparent and efficient manner,” he said.
Once the name change is approved then the Government of India may direct all states to incorporate similar names in their states for administration of drugs like respective State DA (Drug Administration) or Respective State FDA (Food & Drug Administration) to bring in uniformity throughout country.
At the same time the Government of India should also introduce the Indian Drug Services (IDS) examination through UPSC for candidates to lead the IDA. This examination needs to be designed on par with the Indian Administrative Service (IAS), Indian Police Service (IPS) and Indian Foreign Service (IFS).
This IDS cadre may be known as Drugs Control Officers instead of Inspectors. They could be selected through UPSC and posted to various State DA or State FDA like that of IAS/IPS/IFS cadre. As and when required their services could be obtained or on deputation to IDA or other departments of health & family welfare, Ayush, food, veterinary, forest, chemicals, fertilizers, agriculture, industry, revenue, patents etc depending on the need. The position would exercise focused drug administration including framing and implementation of policy in consultation with the related ministries. Further, such a system would create a proper hierarchy and bring in a systematic reporting structure which is uniform to both Centre and State, Dr Jagashetty had said in an earlier interaction with Pharmabiz.
Dr Jagashetty, who was also the erstwhile chairman of the DCC sub-committee for Amendments to Drugs & Cosmetic Rules constituted by DCGI, feels that the Indian drug regulatory authority which scrutinizes the worlds’ third largest manufacturing base of pharma products by volume and 14th in value terms needs to have a more powerful image internationally.
In an era where patent expiry opens up opportunities for IDA personnel to approve not only branded biologicals but biosimilar and generic formulations, apart from new drug delivery devices like skin patches and inhalers. This is an age of innovation where information technology reigns and therefore online issue of licenses for sales and manufacturing and instant information of pharma companies will need in-depth skill training.
“It is high time that CDSCO aligns itself to its change of name to IDA to be more appropriate in the current context of developments of Digital India, Make in India, Uniform Code Pharmaceutical Marketing Practices (UCPMP), medical devices policy, price monitoring cells,” said Dr. Jagashetty.
With Indian market benefiting from quick product regulatory approvals in bio-similars, the recent revision in guidelines by Central Drugs Standard Control Organisation (CDSCO) has made it more aligned with global regulations.
Besides this, regulatory landscape for biosimilars has been evolving with the global pioneer European Medicines Agency (EMA) also setting the trend, say experts.
Biosimilars are copy versions of already approved originator biologics that are marketed after patent expiry for the originator product. As the safety and efficacy of the innovator product is already established, copy versions are allowed to be developed and evaluated using an abbreviated pathway established on biosimilarity principles.
Since the first set of over-arching guidelines for biosimilars were released by the European Medicines Agency (EMA) in 2005, there has been much development in this space. The US Food and Drug Administration released its first set of draft guidelines in 2012, which have since been finalised. Additional guidelines were released in 2014-15. China FDA released its biosimilars guidelines last year.
However some experts like Dr Charu Manaktala, senior medical director, Biosimilars Centre of Excellence, Strategic Drug Development, QuintilesIMS Asia pinpoint, “The general principles of what the regulators expect, such as step-by-step development, focus on robust comparability and functional interests, pharmacovigilance – all of these are aligned with other guidelines.
She says that some points in the recent provision are contentious like the number of subjects required for different phases of development, but we need to have a more pragmatic view.
Compared to the pre-2012 era, she adds, “We have made significant progress. There is scope for revisions to further align our guidelines with the world view, but we are in a relatively good position.
“The basic regulatory framework for biosimilars registration has been established fairly well by 2016. The year also marked the 10th anniversary for approval of the 1st biosimilar in the EU. A number of regulatory guidelines are in place as well as a good amount of experience has been gained on a number of biosimilars ranging from simple proteins to complex monoclonal antibodies. Some of the other highly regulated markets such as Japan, South Korea, Canada, Australia among others have adopted EU biosimilar guidelines to a large degree,” Dr Manaktala concludes.
In addition to the revision of some of the earlier guidelines, the EMA published guidelines for pharmacovigilance of biologics in 2016. The US FDA has published a guidance on the labelling of biosimilars in March 2016.
The naming of biologicals and interchangability of biosimilars continue to be hotly debated topics. The EMA has approved biosimilars under the same non-proprietary name as for the reference product. In 2015, the US FDA issued draft guidance on the subject of non-proprietary naming of biosimilars. This guidance recommends that all biologicals should have non-proprietary names that includes a four-letter suffix to distinguish them from each other. The suffix would be composed of four lowercase letters and not carry any meaning.
The proposed approach is intended with a view to clearly identifying biological products to improve pharmacovigilance, and, preventing any unintended substitution. However, a number of industry stakeholders, including the USP have requested for alternative approaches to be considered.
While the interchangability guidance from the US FDA is awaited, Sandoz recently reported study findings that show lack of safety and efficacy impact from multiple back and forth switches between the it’s etanercept biosimilar and the originator product.
“We expect to see more products obtaining marketing approval on the basis of lean clinical data packages especially where validated PD markers are available, supported by strong quality comparability, in vitro biological activity evidence and clinical PK-PD studies,” adds Dr Charu Manaktala.
Asian manufacturers, especially from South Korea, continue to be key players in the current biosimilars landscape, with rich product pipelines as well as a number of approved products in both the EU and US.
South Korea is reported to have a goal of controlling 22% of the global biosimilars market by 2020. This goal is supported by the Korean government by way of providing capital as well as regulatory assistance to the domestic bioplharmaceutical companies.
The Union ministry of Ayush will soon amend the Drugs and Cosmetics Rules, 1945 to prohibit misleading advertisements of Ayurveda, Siddha & Unani drugs.
Presently, there are no regulatory provisions for pre-censorship on advertisements. Action is taken whenever violation of Advertisement Code is brought to the notice of the Ministry of Information and Broadcasting or the advertisement is found to be in contravention of the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.
In fact, the Ministry in consultation with Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) had already framed and notified draft rules for prohibition of misleading advertisements of Ayurveda, Siddha and Unani drugs in the Official Gazette vide GSR No. 396(E) dated 4th April, 2016 to amend the Drugs and Cosmetics Rules, 1945.
At present, complaints about the misleading content of the advertisements of ayurvedic medicines received in the Ministry of Ayush from any source are forwarded to the concerned State Licensing Authorities with the direction to take necessary action in accordance with the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Drugs & Cosmetics Act, 1940 and Rules thereunder. In several cases, the state authorities have reported to have taken actions.
The ministry is now amending the law as it is aware of the sale and advertisement of ayurvedic medicines through TV channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and Rules framed thereunder.
At present, there are some mechanisms in place for quality control of products sold or promoted through advertisements. Ministry of Information and Broadcasting has constituted an Inter-Ministerial Committee to look into the violations of advertisement code suo-moto or whenever violations of the advertisement code are brought to the notice of the Ministry in respect of private TV channels. The Inter-Ministerial Committee meets periodically and recommends actions in respect of alleged violations reported. An advisory was also issued by the Ministry of Information and Broadcasting on 21.8.2014 advising all TV channels not to telecast advertisements which were found to be violating the provisions of Cable Television Networks Rules, 1994, Advertising Standards Council of India (ASCI) Code and also Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954.
As part of the self-regulatory initiative of the industry, Advertising Standards Council of India (ASCI), a voluntary body of advertisement industry, promotes self-regulation of advertisement content by monitoring and deciding on complaints against advertisements making misleading, false and unsubstantiated claims of the products including ayurvedic medicines.