Centre removes ICMR approval for Import/Export of biological samples

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In another bid to give momentum to research and clinical trials in the country, the centre eased regulations governing the import and export of human biological samples for commercial purposes. The Directorate General of Foreign Trade issued a notification, August 4, saying that the import and export of such samples “should be permitted by Customs authorities at the port of entry / exit without prior approvals (import licence / export permit) from any other Government agency.”

As long as “the concerned Indian company/agency submits an undertaking that they are following and will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples being imported/exported as per the related norms/regulations” to the Customs authority at the port of entry or exit, any other approval is no longer required. Prior to this change, such a company or agency had to submit an application to the Indian Council of Medical Research, which then made decisions case-by-case.

In 2011, ICMR had formed a committee of experts, chaired by the director general of the Council, to scrutinise and, only then, clear every sample going in and out of India. Among the documents that had to be submitted to the committee was a copy of the informed consent of the individual patient agreeing to their sample being used for a particular study.

The debate over the ethics of the commercial use of the biological samples has been around for over a decade now. A November 2002 article from the British Medical Journal notes the objection raised by Indian scientists to a genetic study done by British and German scientists on people from coastal Kerala. The article says the concern was that India’s diverse genetic information could be mined for commercial purposes without regulations.

This notification comes on the heels of two circulars issued by the Central Drugs Standard Control Organisation that also made getting approvals for and the logistics of clinical trials and research easier for companies. All three steps have been taken at the same time as the ICMR bringing out its draft National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, which set standards for ethical practices and consent, and safeguard participants.

One circular removed the cap of three trials per investigator. The other says that trial sites no longer need to have at least 50 beds. Both circulars hand over the decision making powers to the ethics committee presiding over each trial. It was also felt that since India has too few principal investigators, restricting them to only three trials at a time was not feasible.

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The latest updates from the Health Ministry of India

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Keen to diversify and meet the changing drug regulatory requirements in the country, the health ministry is soon set to revise the Drugs and Cosmetics Rules 1945. This strategic move is aimed at adopting progressive changes, while omitting unnecessary provisions from the rule book to bring in ease in regulations, enforcement and ensure better safety of patients.

To look into this matter, the Centre last week constituted ten separate committees each headed by senior members from the drug controller general’s office which includes joint drug controllers or deputy drug controller (DDCs) along with representatives from different state licensing authority, other government and industry stakeholders having expertise in the respective area. This committee will be responsible to deliberate and examine various provisions in the current rules and give their observation and suggestions on the changes needed in the rules either by amending the rules to include new ones as per current needs or omit the ones that have no importance in current regulatory context.

A highly placed source closely associated with this development informed that each group has been assigned as per key chapters in the rules. There is a group to study rules relating to good manufacturing practices (GMP) requirements; group to oversee sales and manufacturing of drugs; a separate group to examine import and export aspect; group to examine clinical trials and approval of new drugs; groups for studying rules relating to cosmetics; veterinary drugs; OTCs; biological drugs; stem cells and regenerative medicines and a group to examine phyto-pharmaceuticals.

“The current rules under the D&C Rules 1945, that are enforced through out the country is too outdated as they were drafted in pre independence era. Though amended several times, it definitely is high time to focus on revising the whole set of rules to meet our current challenges and regulatory compliance requirements. This will be a progressive step towards further strengthening the enforcement parameters which is key to ensure public health,” stated Dr H G Koshia commissioner of Gujarat FDCA. He is also part of the group set up for the examination of provisions relating to sale of drugs.

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Centre issues revised Sch M-III notification for medical devices

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The Centre has finally released the much anticipated revised Schedule M-III notification that is aligned with IS/ISO 13485. Experts see this as a first concrete step towards adopting a separate medical device regulation in the country, an urgent need of the hour to safeguard the interest of the industry. There has been no specific regulation for medical devices and has been irrationally linked with pharma sector through common statute.

Revised Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering device master files and site master files. With this notification of Schedule M-III, the sector will now be able to explore new business opportunities as it will now open up for investments into R&D that will enable India to emerge as a world class-manufacturing hub for medical devices.

Rajiv Nath, forum coordinator of AIMED pointed out that this comes as a huge victory to that sector that was long struggling to have a foothold in this country due to lack of any government support leading to unfavourable market condition for the domestic players. He said that such neglect towards the sector had a detrimental impact on medical device industry making India import dependent.

Until now, Drugs & Cosmetics Act, 1940, governed the medical device sector, which has very different R&D, technologies, production and taxation requirements from that of phrama sector. Industry had been pushing for changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and international ISO 13485 standard for regulatory purposes.

Nath who is also the joint coordinator of the Indian Medical Devices Regulatory Review Group (IMDRRG) added that overseas and Indian investors were always apprehensive to invest in medical device sector since it had pharmaceutical type GMP demands imposed by regulators in an arbitrary manner. Experts stressed that the sector was always incorrectly and incompletely regulated by unsure inspectors.

“We are glad that the government has started taking strategic measures to address the issues and challenges of the industry. With the active support of the Centre we will sure be able to develop India as a manufacturing hub for medical device sector,” he added.

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Should Online Pharmacies be regulated by DCGI?

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The Indian Internet Pharmacy Association (IIPA) has urged the Drug Controller General of India (DCGI) constituted sub -committee formed under the chairmanship of Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshdeep Kamble on online pharmacy to help set up a registry of online pharmacies to ensure clarity on the legitimate players and frame interim guidelines.

In most countries, the legitimate players are given specific operating licenses that are shared with consumers to fight the menace of cross border internet pharmacies. IIPA recommends a similar model for India, and also a crackdown on all illegitimate players, online and offline.

Meanwhile, Maharashtra FDA Commissioner has also maintained that online pharmacies can sell only OTC drugs and not prescription drugs until the guidelines are framed.

IIPA is a group of online pharmacies represented by 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com, SaveOnMedicals and Savemymeds.

IIPA has pinpointed that there are multiple online pharmacies operating from different parts of the world that need to be monitored. This according to them will enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

According to IIPA, online pharmacy is currently governed by Information Technology Act, 2000 and Drugs and Cosmetics Act, 1940.

The Drug Controller General of India had earlier directed all the state/UT drugs controllers to keep a strict watch on online sale of drugs and take action if there is  violation of the Drugs and Cosmetics Act and Rules there under.

Recommendations from all stakeholders are currently being reviewed by the Sub-Committee constituted by the 48th Drug Consultative Committee under the chairmanship of Maharashtra Food and Drug Administration Commissioner to formulate guidelines on the use of information technology in online pharmacy and authorise its legal validity.

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Health ministry issues Revised Draft Guidelines on Similar Biologics

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The Union health ministry has issued the ‘Revised Draft Guidelines on Similar Biologics’ to lay down the regulatory pathway for marketing authorization of similar biologics in the country.

These guidelines, prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for similar biologics.  These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post-market regulatory requirements for similar biologics.

These guidelines apply to similar biologics that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as use of recombinant DNA technology. The demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic. Similar biologic can only be developed against the reference biologic that has been approved using a complete data package in India. In case the reference biologic is not authorized in India, it should have been approved/licensed and marketed in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.

Any product can be considered as similar biologic, only if it is proven to be similar using extensive quality characterization against the reference biologic. Further product development should only be considered once the similarity of the similar biologic is demonstrated in quality to a reference biologic. These guidelines are applicable for similar biologics to be developed in India or imported into the country for marketing authorization.

These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time.

Presently, several organizations are actively engaged in manufacturing and marketing of similar biologics in India. So far, these similar biologics were approved by RCGM and CDSCO using an abbreviated version of the pathway applicable to new drugs on a case by case basis. Since there are several such products under development in India, both regulatory agencies considered the need to publish a clear regulatory pathway outlining the requirements to ensure comparable safety, efficacy and quality of a similar biologic to the reference biologic. Based on demonstration of similarity in the comparative assessment, a similar biologic may require reduced preclinical and clinical data package as part of submission for market authorization.

The objective of this document is to provide guidelines to applicants to enable them to understand and comply with the regulatory requirements for the market authorization of similar biologics in India.

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