HONG KONG – Indonesia, home to the largest Muslim population in the world, wants to lead the way in developing a simpler halal certification pathway for pharmaceutical and biomedical products. Some observers worry, however, that full implementation of laws that completely marry the needs of Muslim Sharia Law and those of traditional drug approval and certification pathways may prove impossible.

Still, Indonesia is trying with a series of new laws and regulations that consolidate and simplify existing rules. And the approach there may be one that regulators elsewhere, particularly in the Islamic countries in the Middle East and North Africa (MENA), may seek to emulate.

In October 2014, former President Susilo Bambang Yudhoyono signed Law No. 33 on Halal Product Assurance, which creates a one-stop system for drugmakers looking for halal certifications for their products.

The new law created the Halal Product Security Agency (BPJPH) to oversee the process and provide ongoing certifications for products.

“The government introduced this new law to adopt a single legal instrument that covers everything,” said Alexandra Gerungan, a partner at Makarim & Taira S, an Indonesian law firm.

Indonesia’s new law is bold and goes much further than regulations already in place in countries in the MENA region. By the time it is fully implemented in 2019, the law will require “products that enter, are distributed and are traded in Indonesia to be halal certified.”

Law No. 33 requires halal certificates and labels for three sectors – food and beverages, cosmetics and pharmaceuticals – and goes further than most in that it requires not just final products but also all equipment and raw materials used during the production process to be halal, or acceptable under Sharia Law.

The new law means the BPJPH will be the only institution with the power to issue halal certificates to drugmakers, while a Halal Inspection Institution (LPH) will be responsible for checking how raw materials are processed at various manufacturing facilities.

The new law also limits the role of religious authorities – in this case the Indonesian Ulema Council (MUI), which will now be limited to setting standards for products to be considered halal. The MUI currently oversees all halal certifications, including those of pharmaceutical and biomedical products, through its Food, Drug and Cosmetics Assessment Agency. Indonesia’s Minister of Religious Affairs put the MUI in charge of halal certifications for food in 2001, when it passed MORA Decree No. 519.

“It mainly referred to food, but actually it refers to any product that is consumed by humans, and then in practice this decree became the grounds for the MUI to implement its function as an institution to certify products as halal. Eventually, it included biomedical products, including medicines, vaccines and so on,” said Parulian Simanjuntak, executive director at International Pharmaceutical Manufacturer Group.

The MUI often took a fairly inflexible approach and by the end of 2013, there were just 22 biomedical products with MUI halal certification, said Makarim & Taira ‘s Gerungan.

“The council applies a very strict standard compared to other countries because in Indonesia, Islam is the main religion,” said Gerungan. “A simplified system may boost the number, and that is the spirit of the new law.”

Although the new law puts halal certification in the hands of lay rather than religious authorities, it does go further than the old system in some areas. For example, it links some investment approvals to halal certification.

MEETING HALAL REQUIREMENTS

The requirement for halal certification adds one more regulatory layer for pharmaceutical companies looking at the market. Products not only have to move through more traditional regulatory pathways, complete with various clinical trials, but also meet halal requirements that often ban the use of porcine products, for example. Those requirements often make it difficult to ensure some vaccines are produced under halal standards.

“For the time being, it is quite complicated if a pharmaceutical company would like to produce a biomedical product and get a halal certificate,” said Gerungan. “The spirit of the new law is to create the one-stop system and to simplify the procedure.”

There also has been some controversy, often stemming from different interpretations of what is and isn’t halal.

For example, in 2010, pharma giant Novartis AG said its Menveo vaccine, developed for Hajj pilgrims, had officially received a halal certificate from the MUI. It did not take long for questions to surface about the company using substances made from swine in its vaccines.

“Menveo is not porcine-free,” Muhammad Chaudry, president of the Islamic Food and Nutrition Council of America, an international halal certifier, told media in 2012.

A number of questions remain, including who will make up the BPJPH and how the body will be established. It is also unclear how the BPJPH, MUI and LPH will work together.

And the new law creates new risks, including the possibility of imprisonment for up to five years and fines of $164,000 for companies that fail to maintain the halal process.

Some believe that, ultimately, it may be too difficult to meet the needs of both religion and health care. After all, the requirements for halal certification are, basically, over and above the need to ensure efficacy, safety and quality.

“While this is expected to come into force by 2019, we believe a full implementation of this policy will remain unlikely, as it will create further challenges for both the local pharmaceutical industry and health care access,” said Ang Wei Zheng, an industry analyst at Business Monitor International. “This new law comes with strong legal powers.”