Malaysia leads global halal pharmaceutical industry
26 Dec 2023
Halal pharmaceuticals are ranked 2nd after the food industry in terms of size, says Amrahi
The halal pharmaceutical industry in Malaysia has grown and developed in recent years. Focusing on adhering to Islamic principles in the production and distribution of medicines, Malaysia has become a leader in halal pharmaceuticals, supported by stringent certification processes, regulatory bodies and industry collaboration.
The Evolution of Halal Pharmaceutical
Malaysian halal pharmaceuticals have gone a long way and it is under the jurisdiction of the Department of Islamic Development Malaysia (Jakim).
Malaysian Pharmacists Society (MPS) president Prof Amrahi Buang said the industry has evolved since the introduction of the Halal Pharmaceuticals Standard MS2424 in 2012, expanding to include biopharmaceuticals in the 2019 edition.
“Halal pharmaceuticals are ranked second after the food industry in terms of size, while the uptake has increased from year to year since 2012,” he told The Malaysian Reserve (TMR).
Meanwhile, Farmasi Al Arif Sdn Bhd CEO Muhammad Farahi Arif said the industry’s growth is notable, with the Malaysia export value of halal pharmaceuticals reaching RM401 million in 2019, compared to RM395 million in 2018.
“The growth can be attributed to rising global demand for halal-certified products, including medicines and healthcare items.
“The rising Muslim population worldwide and the supportive government initiatives also facilitate the development of the industry,” he told TMR.
Muhammad Farahi also emphasised the preventive care segment’s growth, reflecting a broader market shift towards holistic health approaches.
Leading the way are key players such as Duopharma Biotech Bhd, Pharmaniaga Bhd, and Ain Medicare Sdn Bhd, together with the Halal Development Corp Bhd (HDC) playing a crucial role in supporting the industry at both national and international levels, while also paving the way to more new players in the halal pharmaceutical industry.
Ideal Nauticare Sdn Bhd MD Muhamad Faris Badarudin said robust regulatory frameworks, international collaborations, effective marketing highlighting halal certification, and active participation in global trade events further enhance Malaysia pharmaceutical’s presence.
“Leveraging Islamic finance support, Malaysian companies continually invest in technology and production capacities, solidifying their role as key players in the expanding global halal pharmaceuticals sector,” he said.
Meanwhile, a source in the industry told TMR that industry leaders not only demonstrate a commitment to halal compliance but also underscore their standing as key players shaping the landscape of the halal pharmaceutical sector in Malaysia.
“This surge in interest extends beyond local markets, with companies aiming to penetrate the international markets, reflecting the industry’s broader reach and potential for sustained development,” he added.
Jakim Certification Processes and Standards
To achieve halal certification, pharmaceutical products must be registered with the National Pharmaceutical Regulatory Authority (NPRA) before undergoing a voluntary halal audit by Jakim.
“The certification decision is business-driven. Jakim has comprehensive halal audit guidance in addition to compliance to Halal Pharmaceuticals standard MS2424,” said Amrahi.
He added that Jakim oversees the certification processes and sets stringent standards for halal pharmaceuticals in the country.
“These standards encompass the sourcing of raw materials, manufacturing processes, handling, and distribution of pharmaceutical products,” he told TMR.
Meanwhile, Muhammad Farahi said the NPRA oversees product registration, ensuring adherence to Good Manufacturing Practice (GMP) standards.
“This covers quality, safety, and efficacy, aligning with the concept of ‘halal toyibban’ in the halal framework,” he added.
He also stressed the importance of NPRA in making halal certification compulsory, highlighting their role in maintaining the integrity of halal pharmaceuticals.
“They monitor adherence to halal standards, ensuring all medicines meet the necessary criteria. NPRA makes it compulsory for declaration of any animal sources in pharmaceutical ingredients or products,” he said.
Muhamad Faris elaborated more on Malaysia halal pharmaceutical’s high credibility and trust which complies with the framework that aligns with international pharmaceutical regulations.
“This dual assurance of halal integrity and quality from HDC and Jakim enhances Malaysia’s competitiveness in the global market,” he said.
He added that pharmaceutical companies must meet the requirements of both bodies under the Halal Pharmaceuticals Standard MS2424, incorporating regulatory and halal aspects.
“Pharmaceutical companies are required to adhere to NPRA’s standards and the Drug Registration Guidance Document (DRGD), which explicitly incorporates the halal parameter to further ensure compliance with halal principles.
“Bodies like Jakim and State Islamic Department in all states are actively organising discussions, exemplified by events like the annual National Executive Halal conference, further reinforcing the collaborative efforts to ensure the alignment of pharmaceutical practices with halal standards,” he said.
Although it seems hard to maintain Malaysia as the leading global halal pharmaceutical, Muhammad Farahi said there are also several companies going the extra mile to embrace the challenges in developing the industry such as Duopharma Biotech (manufacturing and logistics) and Farmasi Al Arif (retail and logistic).
“These entities work together to interpret Islamic principles and apply them to pharmaceutical manufacturing processes, seeking guidance from scholars to ensure compliance,” he added.
Developments in Halal Pharmaceutical Industry
Amrahi said the government has positioned halal-certified pharmaceuticals as a major economic initiative for post-pandemic economic recovery.
Halal Pharmaceuticals Standard MS2424, which describes the general guidelines in the manufacturing and handling of halal pharmaceuticals ensures the incorporation of halal principles throughout the manufacturing process.
This not only guarantees the halal integrity of the final product but also provides industrial players with a competitive edge.
TMR’s industry source said these initiatives encompass various measures, from providing incentives for companies obtaining halal certification to offering research and development grants, which help foster international collaborations to elevate Malaysia’s position in the global halal pharmaceutical market.
“The government has implemented the Halal Industry Master Plan 2030 (HIMP 2030), a comprehensive framework aimed at leveraging Malaysia’s strengths for the holistic development of its halal industry,” he said.
He also said events such as the Malaysian International Halal Showcase (Mihas) play a pivotal role in the industry.
“Mihas serves as a platform for local and global halal certification bodies to converge, fostering collaboration and promoting the growth of halal industries,” he added.
As for Muhammad Farahi, he is confident that Malaysia’s halal pharmaceuticals can stay as the main player in the global scene.
“Malaysia, as a pioneering country in the halal pharmaceutical industry with the establishment of the first standard for halal pharmaceuticals, MS2424:2019 should spearhead the development of the industry, in terms of regulation and production,” he said.
Role of Halal Certifying Bodies
Being the pioneer of halal pharmaceutical practices, Muhammad Farahi believes that halal certifying bodies play an important role in verifying and endorsing the halal status of pharmaceutical products in Malaysia by conducting inspections, audits, and assessments.
Halal certifying bodies in other countries must strictly adhere to Jakim’s requirements, and Jakim recognises the halal logo of a country once the certifying body is recognised. This ensures consistency and reliability in halal certification.
Malaysian companies face the challenges of meeting global standards, but it also creates opportunities through the OIC/SMIIC Technical Committee on Halal Pharmaceuticals (TC16).
He said Malaysia, currently leading TC16, plays a vital role in setting global halal pharmaceutical standards.
“The Malaysian halal logo is the most trusted logo in the world,” he said.
Meanwhile, Muhamad Faris said in the context of exports, the country leverages its established halal certification processes, combining Islamic standards with international pharmaceutical regulations.
He noted that Malaysia actively attracts investments, fosters collaborations and supports local companies to innovate in halal pharmaceuticals.
“This strategic approach not only facilitates the export of halal medicines but positions Malaysia as a centre for advancing research, development and technological innovation,” he said.
Muhamad Faris also said several Malaysian pharmaceutical companies, notably Pharmaniaga and Chemical Co of Malaysia (CCM), have witnessed success in exporting halal medicines globally.
However, TMR’s source said Malaysian pharmaceutical companies encounter challenges as they seek global expansion.
These include diverse halal certification standards and guidelines, a lack of initiatives from foreign governments or authorities, as well as inconsistent enforcement of mandatory halal certification.
“There are also variations in the approach to halal certification processes and evaluation, differing interpretations of halal standards based on various schools of thought or ‘mazhab’, and a shortage of expertise in navigating these complexities.
“Despite these challenges, the global expansion also opens doors for Malaysian companies to demonstrate their expertise in producing high-quality halal pharmaceuticals,” he said.
TMR reached out to Jakim but it was unable to comment by press time.
Source: The Malaysian Reserve
