Over half of the companies in the Rs 8,000-crore Ayurveda industry default when it comes to compliance with the regulatory requirements of domestic manufacturing standards, highlights an internal data of the health ministry. The data was compiled in collaboration with state drug regulators of the country.
Of the total 9,807 units in the country that manufacture Ayurvedic, Unani, Siddha products, around 5,474 units have been found to be not conforming to even the prescribed domestic requirements of good manufacturing practices, let alone the stringent norms of the WHO and US FDA.
Of the non-complying units, around 45% have already been sent legal notices by the state drug licensing authorities. Adhering to the good manufacturing practices, prescribed in the Schedule T of the Drug and Cosmetics Act is a statutory obligation of the company, after the government notified the same in 2000.
Among states, Uttar Pradesh which houses the largest number of units in the country, 3,683 units, also tops the chart in the absolute number of defaulting units which stand at 53% of total units in the state. Around 1,600 units in UP alone have been sent legal notices. In Kerala, 761 units of around 1,271 units have failed to comply with domestic manufacturing requirement. Around 79% of the total defaulting units are restricted with the six states of UP, Kerala, MP, Maharashtra, Gujarat and Haryana, which together constitute 72% of total units. The data reveals that over 90% of units in Madhya Padesh, 83% in Tamil Nadu, 75% in Uttarakhand have failed to conform to domestic standards.
Industry concedes that quality is the biggest hurdle in its growth process, both in case of domestic market and exports. ?This is why Ayurveda hasn?t evolved as a full fledged independent medicine system. The stream has to contain itself as a supplementary medicine system, mainly selling in the form of over the counter drugs,? said Ranjit Puranik, CEO of Mumbai-based Shree Dhootapapeshwar Ltd and general secretary, Ayurvedic drug manufacturing association. Puranik added that at this rate, India may just miss the bus when it comes to grabbing a pie of the global herbal market worth $120 billion.
?Each such violation must be dealt with very seriously. Otherwise what incentive do companies have with the exception of a moral duty to invest in quality and sell a product at a rate higher than that of manufacturers who are compromising on quality,? said Puranik. The CMO of Hamdard (Wakf) Labs, Arshad Siddiqui, a leading Unani player said, ?Many companies are selling traditional medicines which don?t measure up to the government specified standards. The reason could range from poor quality of raw material, contaminated herbs with excessive banned pesticides or metal, sub-standard handlers and processors used in the manufacturing of these medicines. These products either don?t produce desired effect or could have negative effects on the user tarnishing the image of traditional medicines not only in the global arena but in the domestic market as well?. He, however, added that drug manufacturers are increasingly moving towards GMP. Part of the problem springs from the fact that close to 90% of industry comprised of micro, small and medium enterprises, rendering task of implementation of any scheme a huge challenge.
The secretary of department of AYUSH S Jalaja told FE that ensuring quality in Ayurvedic products in the market figures among the top priorities of the government, and the department has adopted a multi-pronged approach to tackle the issue, ?The government is already running a scheme for companies with an annual turnover of up to Rs 20 crore, which can get assistance from government to acquire quality control equipment for an in house quality control lab with an upper limit of 30% of expenditure incurred, or Rs 30 lakh,? said Jalaja.
She added that the department has just launched a quality control system in which Ayurvedic drug manufacturing companies would need to get their products validated by the third party certifiers authorised by the autonomous body Quality Council of India (QCI), mainly on the parameters of purity levels and good manufacturing practices. She also said the department is implementing a cluster scheme with an investment of Rs 100 crore that aims to fill up critical gaps related to standardisation, quality control, productivity, marketing, so that benefits of economies of scale can accrue to the participant companies. She expressed the hope that industry accords top priority to quality issues.
