The Food and Drug Supervisory Agency (BPOM) has asked the Indonesian pharmaceutical industry to make research the basis for business development and thereby, realize the independence of the domestic health ecosystem.
“The COVID-19 pandemic has become a momentum for encouraging many research and development initiatives, both for drugs and vaccines, which aim to treat and prevent the spread of COVID-19,” Head of BPOM, Penny K. Lukito, said at a domestic drug development workshop here on Friday.
Indonesia has great potential for drug development due to its wealth of natural, maritime, and biodiversity resources, she added.
However, until now, the Indonesian pharmaceutical industry has continued to rely on imported raw materials and drugs, especially drugs that are produced using high technology, she said.
Indonesia has not become an inventor in the research development sector, Lukito noted.
Therefore, the BPOM organized the “Workshop on the Utilization of COVID-19 Drug and Vaccine Development Technology to Support the Development of Domestic Drug and Vaccine Self-Reliance Ecosystems.”
The workshop sought to build the understanding of policymakers, researchers, and business actors within the triple helix framework to encourage the development of an ecosystem for drug and vaccine development in Indonesia.
“All research and development must be supported to help commercialize research products and provide benefits to the wider community,” Lukito said.
The workshop involved various stakeholders and related sectors, including the Coordinating Ministry for Economic Affairs, the Coordinating Ministry for Human Development and Culture, the Ministry of Health, the National Research and Innovation Agency (BRIN), and representatives from educational institutions, the pharmaceutical industry, and associations.
During the workshop, BPOM introduced several public service innovations, including the NEW-Aero Webchat to help registrants share problems related to drug registration.
BPOM also introduced the SISOBAT Subsite for accessing the latest information related to drug regulations; products made by the Directorate of Standardization of Drugs, Narcotics, Psychotropics, Precursors, and Addictive Substances (ONPZZA); and inputs related to Norms, Standards, Procedures, Criteria (NSPK).
The agency also introduced SMART CDOB to accelerate the issuance of Good Drug Distribution Method (CDOB) certificates and the CLICK CPOB Subsite, which will make it more convenient for researchers to apply for Good Manufacturing Practices (GMP) regulatory assistance for innovative drug development facilities.
BPOM also launched two books related to drugs: Smart Way to Prevent Illegal or Fake COVID-19 Drugs and Vaccines and Maintaining the Integrity of the COVID-19 Vaccine Supply Chain at Pharmaceutical Service Facilities.
In addition, a GMP certificate was officially handed over to PT Biotis for upstream and downstream facilities for the production of inactivated vaccines that meet GMP requirements.
“With today’s series of activities, I hope that researchers and pharmaceutical industry partners have an understanding regarding the fulfillment of standards and requirements for drug research and development,” Lukito said.
Source: Antara News