Ayurveda DC dept in Kerala weak in enforcing laws as drug cos not complying with API provisions: Experts

Monday, July 3, 2023

The Ayurveda drugs control department in Kerala is alleged to be weak in its performance of enforcing drug laws as many of the traditional drug manufacturers are said to be not complying with the provisions mandated by the Ayurvedic Pharmacopoeia of India (API) to ensure the safety and purity of the drugs they manufacture and sell to patients, according to senior Ayurveda professionals and industry experts.

Among the 600 manufacturing units in Kerala, only a few are strictly following the rules as per Indian Ayurveda pharmacopeia which illustrates the standards of quality, purity, and strength of the drugs that are manufactured, distributed, and sold by the licensed manufacturing companies in the country. Based on these provisions the Ayurveda section in the Drugs and Cosmetics Act was framed, opines Dr. Joy Varghese, the Ayurveda industry expert and architect of the Kerala Ayush cluster, Care Keralam.

According to him, the apathy of the Department of Ayurveda drug control in enforcing the provisions of the Drugs and cosmetics act helps the manufacturers skip the mandatory provisions and market their products at their will. No officer designated to inspect the premises of the manufacturing unit or the sale counters is conducting a random check or taking samples for a quality test. The manufacturers produce the required test reports at the time of submission of applications for licenses for the satisfaction of the licensing authorities, but afterward, the regulatory officers do not trace the manufacturers to confirm whether all the batches of the drugs they supply to the market in later periods are passing through the mandatory tests.
 
Dr. Joy says that some prominent companies who are exporting the products as health supplements to foreign markets conduct the tests for their business purpose, but for domestic sales, nobody conducts the tests after receiving the drug license.
 
Meanwhile, sources close to the drug control department told Pharmabiz that drug licenses are issued to manufacturers even without producing the report of the stability study test which is mandatory for issuing a license to a manufacturer. The Ministry of Ayush brought a rule in this regard in 2016 and three years was given as a grace period for making it as a pre-condition. The rule came into effect in 2019, but nobody is following it.
 
When Pharmabiz contacted Dr. Jaya V Dev, the drug controller in charge of Ayurveda, she said the department fulfills all conditions of licenses and the drug inspectors are doing their duties of inspection and sample collection regularly. Meanwhile, the state drug controller Sujith Kumar, under him the Ayurveda department is functioning, said he will enquire about the allegations with the Ayurveda drug control administration.
 
Dr. Joy Varghese said the Ayush cluster of Kerala, established at Koratty in Thrissur district, has all the facilities to conduct microbiological tests of TPC (Total Plate Count which is a method of estimating the total number of microorganisms in a material), Heavy Metal Tests, Pesticide Residue Test and the Aflatoxin Test which are necessary for getting a new drug license from the regulatory body. He said if the department insists on the provisions, the manufacturers will do all the required tests for every batch of their products so that quality medicines can be sold in the domestic market. The responsible government agency to persuade the manufacturers to comply with all the provisions of the D&C Act is the drug control department which fails in their work, he alleged.

An Ayurveda expert who follows the industry in every aspect and observes the system closely, while interacting with Pharmabiz said, it is the right of a patient to know what are the contents of the drug that he consumes and whether its quality is ensured or not. To prove the quality of the contents, a manufacturer should conduct a test of the HP TLC technique for purity analysis of the chemicals contained in the drug. He also alleged that very few manufacturers are using this technique in Kerala and it seems that the drug control department is not worried about it. As a result, the quality of drug substances cannot be proven.

PHARMABIZ.com