“Many people are under the impression that the ingredients of the medicines come from deep in the forests or from untouched land, but this is not true,” he said.
Jaiminy said that although audits are being conducted on the process of manufacturing, there are no tests on the raw materials or finished goods.
“The regulatory standards are available. However, there is a huge manpower crunch in drug inspection and this is especially so in traditional medicine inspection,” said Anil Jauhri, director of the National Accreditation Board for Certification Bodies (NABCB), a unit under the Quality Council of India.
Responding to the increasing popularity of Ayurveda, Siddha, Unani and other traditional medicine systems, the government made a number of amendments to the Drugs and Cosmetics Act between 2008 and 2010.
In 2009, good manufacturing practices (GMP) were introduced to “establish the authenticity of raw drugs, minerals and metals in processing of validation and quality control parameters.” It was also recommended that all products be given an expiry date considering that their potency diminished over time.
A Pharmacopeia Commission for Indian Medicines was established in 2010 which would, among other things, maintain a repository of reference standards that can be used in manufacturing traditional medicines.
The problem, however, lay with the implementation of regulations.
“…most Ayurvedic manufacturers do not have elaborate quality and safety testing infrastructure,” said Rangesh Paramesh, head of drug discovery at Himalaya Drug Co. “Limited funds coupled with low awareness of safety processes makes testing less prevalent.”
The problem is particularly acute in the unorganized sector. “The unorganized sector largely operates outside the ambit of the regulatory framework and hence may not be complying with all safety and quality norms,” Paramesh said.
To encourage manufacturers to follow prescribed standards, the NABCB, along with the department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in 2009 started a voluntary certification scheme in which companies are awarded a quality seal after a third-party audit to check their compliance with GMP and other regulatory requirements.
The seal, which is an indication of product quality, enables consumers to distinguish between compliant drug makers and non-certified manufacturers. A certification mark may also be awarded to companies that want to export their products if they complied with the World Health Organization requirements. Takers for such schemes have been very low. “Till date there have been only seven-eight manufacturers who have availed the AYUSH certification,” said Jauhri of NABCB who was involved in framing the AYUSH scheme. The TÜV SÜD study showed that while there is awareness of the GMP regulations, few know about the AYUSH scheme. Only 8% of the respondents were aware of the AYUSH certification scheme while 81% were aware of GMP. Less than 30% were aware of good labelling practices, good clinical practices and good agricultural practices prescribed for makers of traditional Indian drugs.
Jauhri says to increase participation, the government needs to offer incentives for manufacturers to avail of the certification.
“There are various strategies we are looking to introduce, such as reimbursement of the cost of certification, making it compulsory for government vendors to procure AYUSH products with the quality seal and also make agreements with various countries to accept the AYUSH certification as a demonstration of compliance to their requirements,” said Jauhri. “Also, we will need to create awareness among consumers that will cause a demand-side pressure.”
Ayurveda, the most well-known of traditional Indian medicine systems, is a market worth an annual $1 billion.
“As Ayurveda gains popularity, the regulatory environment is becoming more stringent,” Paramesh says. “Over the next three-four years we will see rigorous enforcement of norms by the authorities, resulting in wider compliance.”