The Central Government has taken steps to promote the quality of drugs. It has made mandatory bioavailability and bioequivalence data before giving product permissions and also mandatory requirement of stability data to ensure quality of drugs.
The Central Government is taking steps to strengthen the Indian drug regulatory system in keeping with the recommendations of the committee constituted under the chairmanship of Union Health Secretary, says S Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO).
Delivering his special address on the topic of Regulations in Pharma on the occasion of two FE Pharma Summit which started on 24th March 2022, he said measures recommended also included a single window system to help applicants or manufacturers get approvals, say for instance for recombinant products.
“Currently, multiple agencies are involved in processing applications and the applicants have to move to different agencies for getting approval of recombinant products through the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology (DBT) and also through the CDSCO,” he added.
In addition to this, there are multiple recommendations made by the committee to bring transparency and accountability in the drug regulatory system. The health ministry committee has also recommended coming up with a new Drugs and Cosmetics (D&C) Act. As per the recommendations, the Central Government has already constituted a committee under the chairmanship of Drugs Controller General of India (DCGI). The DCGI constituted committee has already submitted the report to the union health ministry which is under consideration of the ministry.
Eswara Reddy further explained that in order to make India a global pharma hub, the Central Government has launched two Production Linked Incentive (PLI) schemes for the pharma sector. PLI 1 aims at helping domestic industry gain self reliance in manufacturing Active Pharmacutical Ingredients (APIs), Key Starting Materials (KSMs) and Drug Intermediates (DIs) whereas PLI -2 is meant to make India as a global hub in manufacturing of new drugs, biopharmaceuticals, new excipients, also called as the complex excipients, complex drugs and phytopharmaceuticals .
The Central Government has taken steps to promote the quality of drugs. It has made mandatory bioavailability and bioequivalence data before giving product permissions and also mandatory requirement of stability data to ensure quality of drugs.
It has also made mandatory excipients compatibility studies to ensure compatibility between drugs and excipients in a formulation. Other measures include enhancing the capacity of drug testing labs, training programmes for drug strengthening of states and UTs and making marketing companies also responsible for drugs other than the license holder.
“In order to promote transparency in the regulatory system, manufacturers can now make applications online and get approvals online through IT enabled platforms like SUGAM portal. This has made submission, processing and approvals of applications easy by minimizing human interface. Applicants can also access publication of the recommendations of expert committees on the website. The DCGI office has also set up a PRO office to address queries and concerns of the applicants, Eswara Reddy concluded.
While speaking on the subject of “Regulations & Compliances: Creating Digital Strategies within the Established Framework” Dr Hemant Koshia, commissioner, Food and Drug Control Administration (FDCA), Gujarat said, “Gujarat FDCA has streamlined its regulatory mechanism through efficient use of information technology in the form of its self-licensing software or online platform, Xtended Licensing and Laboratory Note (XLN).”
“The software enables the registration of all the pharmacists and chemists in an authentic way and thereby prevents multiple illegal enrollment of pharmacists. It ensures effective regulation of the sales and manufacturing aspects related to drugs, food and cosmetics and issuance of licenses,” Dr Koshia explained.
“The best part of the XLN software is that it keeps a track on whether retailers and pharmacists are adhering to the provisions of the Drugs and Cosmetics (D&C) Act and rules especially relating to the clause that stresses on presence of pharmacists in the retail outlets,” he further added.
XLN not only helps in transparent and speedy disposal of various licensing applications, it also helps in effective drug recall by reducing the time lag between the collections of samples to dissemination of information to stake-holders.
DMLA software adopted by both Gujarat and Maharashtra generates instant information on the total number of product licenses granted on a real time basis. It also offers easy access to the availability of medicines in stock along with all the details of the manufacturers.
DMLA also gives company profile, certificate issue, inspection, sampling report and fresh firm registration, apart from issuing fresh license, renewal of licenses and additional product permission.
On the subject, D R Gahane, Joint Commissioner, Food and Drug Administration (FDA), Maharashtra said, “Online submission and processing of applications enables regulators to deliver efficient paperless services on time for granting product licenses to the manufacturers without any manual intervention.”
Gahane further added, “The unique feature of the online platforms besides the transparency is the ease of getting digitally signed authentic online licenses and certificates with a unique user ID and password. The online platform also allows users to track the application on a real time basis”.
