Faster Import of Human Biological Samples: No Prior Approval Required!

As per the Director General of Foreign Trade (DGFT) via. the notification on August 4, 2016, (Notification No. 19 /2015-2020), an amendment in the policy of the import and export of biologicals used for commercial purposes has been made. This notification stated that the human biological samples used for commercial purposes can be imported or exported at a faster pace that too without any prior approval viz. there is no requirement of an import license or an export permit from any other Government agency.

What are Biological samples?

Biologicals are pharmaceutical products used for the diagnosis, prevention, or treatment of diseases. They are prepared from live tissues or cells such as vaccines, sera, recombinant products, etc. These products are however, prepared by utilizing the basic biological like serum, tissues and cells, blood, sputum samples etc that contain potentially therapeutic, diagnostic and research applications or can be modified for the same. As these products constitute an important part of the pharmaceutical industry, their import and export is vital so as to maintain the efficacy and safety of the manufactured products. To keep an eye on the quality of the imported products, the regulatory authorities have mandated their prior approval. This also helps keep a tab on the sales and imports of goods in the country as bio-terrorism is a growing threat.

Stringent and Mandatory Approval on the Import and Export of Biologicals

Although prior approval of such products is very essential, obtaining approvals is extremely tedious and time consuming (consumes almost 4 to 5 months), which delays the regulatory process and makes it tedious for the diagnostic laboratories, biotechnology companies, pharmaceutical industries, and contract research organizations (CROs) to follow. This not only leads to delays in the take-off of plans and product launches but also leads to the loss of revenue and man power for the same. A prior authorization of each and every sample to be imported and exported by the Indian Council of Medical Research (ICMR) was mandatory. The time required for the handling and approval of such samples was almost 3 months. The committee time, submission, and receipt of approval took almost half a year, causing immense delays to CRO companies for further procedures. Moreover, there were strict timelines for the submission of applications to the ICMR committee viz. 31st January, 20^th April, 31^st July, and 31^st October. The stringency was tough as no application was entertained in the middle of the term.

Amendment in the Policy leading to the Hassle Free Import and Export of Biologicals

Now, it’s the time for Biotech companies, research centers, and others to relax because the government has changed the policy that allows a time saving, hassle-free, and better way to import and export various biological samples. The amendment in policy focuses on the removal of the mandatory requirement of an export or import license for these samples.

After brain storming, dedicated and tireless efforts of 3 months by the ABLE team, which is headed by Honorary Chairperson, Dr. Kiran Mazumdar Shaw, Founder of Biocon, the great step of amendment was notified by the DGFT on 4^th August 2016 under the Notification number 19/2015-2020 by the director general of DGFT, Mr. Anup Wadhawan.

As per the new notification, to attain the permission on import or export of a biological product, a research or pharmaceutical organization needs to file a self-certification (undertaking) to the customs authority. The self-certification involves a self-statement that assures that the organization is following or shall follow all the rules, regulations, and procedures applicable for a safe transfer and disposal of the biological samples. Responding to the same, the regulatory authorities allow the export and import of the products for further research.

As per the DGFT notification, all the exit and entry points of Custom authorities have been informed prior regarding the revised guidelines so as to streamline the handling of biological samples and make the process glitch-free. Moreover, the software used by the custom department on the customs networks for the import and export of biologicals has undergone appropriate changes.

Notification Basics

As per the Gazette of India Extraordinary Part-II, Section-3, Sub-Section (ii), the amendment will soon be published and states the following:

“The import of human biological samples by the Indian diagnostic laboratories/ Indian Clinical Research Centers for lab analysis/ R & D testing or export of these materials to foreign laboratories should be permitted by the Customs authorities at the port of entry/ exit without prior approvals (import license/ export permit) from any other Government agency, provided the concerned Indian company/ agency submits an undertaking that they are following and will follow all the applicable rules, regulations, and procedures for a safe transfer and disposal of the biological samples being imported/ exported as per the related norms/ regulations set by WHO*/ DGFT** [SCOMET items in the Export Policy of ITC (HS), 2012, Schedule- 2 (Export Policy)]/ Ministry of Environment, Forests and Climate Change***, Government of India, to the Customs authorities at the port of entry/ exit along with the details of such samples”.

Impact of Amendment in Policy

The biotechnology, research, and pharmaceutical organizations are excited about the changes and are looking forward to use the convenient pathway to handle the import and export of the biologicals. Moreover, they are focused to comply with the amendment and self-certification procedure to enjoy the new notification for a long term. These amendments will help in the following ways:

1. Reduce the time spent in applications, follow up, and procurement of both import and export licenses for biologicals
2. Save money for the companies involved
3. Save manpower involved in obtaining the approvals
4. Save manpower, time, and money for the Government in the upkeep and maintenance of these procedures, their officers, etc.

At CliniExperts we understand the value of such time saving maneuvers. For all the regulatory needs, whether or not there are cumbersome processes involved, the trained and skilled professionals of our experienced team are here to assist our clients at every step. We ensure complete client satisfaction and are available even when there are post-approval changes. Our nearly a decade worth’s experience and networking, with a local team and global market understanding is what makes CliniExperts the regulatory partner you need for your brand.