Biologicals are pharmaceutical products that are mainly used for making a diagnosis, prevention, and treatment of diseases. They are obtained from biological sources and can be made from live tissues and other biological sources, hence the name. Since these products are an important part of the pharmaceutical industry, regulating their import as well as exports also important for maintaining the efficiency and safety of the products.
Therefore, to keep an eye on those products, the regulatory authorities had previously made prior approval mandatory. This assists in keeping a tab on the sale and import of such products in the country.
Prior approval of these products is indeed very important but the process of obtaining it is very tedious as well as time taking. It makes the regulatory process delayed and a cause of concern for all diagnostic laboratories, pharmaceutical manufacturers, research organizations. This also results in the loss of huge manpower as well as revenue. Previously a prior authorization of all samples that are to be imported and exported was compulsory by ICMR.
The total time for handling and approval is about 3months, followed by the approval receipt and submission which takes around half a year more.
To avoid all these hassles Director-General of Foreign trade amended the whole policy of import and export for the biological sample being used for commercial purposes. According to this amendment, the human biological samples that are utilized for commercial purposes can be imported exported at a much rapid rate without the necessity of prior approval.
This amendment for hassle-free import and export of biological will help the biotech companies and associated units because it allows saving time and offers a better way of import and export.
According to the new policy, the import-export of human biological samples should be permitted at the port of entry/exit by custom authorities without prior approval. However, the concerned company should file an undertaking to the customs authority, mentioning they comply with all the necessary rules and regulations of the transfer.
This self-certification states that the organization is abiding by the rules, procedures, and regulations for the safe transfer of the human biological samples. The exit and entry ports of custom authorities have been well informed about the revised guidelines so that they can easily streamline the biological samples and keep the process free from any hindrance.
Moreover, the software used by the customs department on the customs networks for the import and export of biological has undergone appropriate changes.
What is the result of these changes made?
● The pharmaceutical sector, including research as well as for biotechnology companies, are satisfied with this new rule and have got a convenient pathway for handling important export.
● It helps in decreasing the time spent on the process of import and export.
This is a commendable step taken by the authorities since it will reduce the overall time and effort involved in the import/export of human biological samples. Thus, empowering medical research and biotechnology is even further.
