Faith under the law

The Ramdev-centred controversy highlights the lapses in government procedures for monitoring the standards of products of traditional medicine businesses

Mamta Sharma Delhi

The new age guru, Swami Ramdev, is accused of violating labour laws in his Divya Yog pharmacy and for not disclosing the ingredients in the ayurvedic preparations at his pharmacy under the Indian Drugs and Cosmetics Act, 1940. 

This controversy, long brewing, came to public attention when eventually the TV cameras panned on communist leader Brinda Karat's support for a group of workers at Ramdev's pharmacy who were paid less, and then fired for demanding their rights. Swadesh Dev Roye, secretary of Central Indian Trade Union (CITU) said that the issue is basically one of a large turnover business exploiting labour. Ramdev, according to him, 'is more of a businessman and less of a yogi'. The labour issue is pending.

Then distractions were provided by allegations of animal and human products being used in the formulations. The point remains that samples of drugs sent by Karat to the department of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) under the health ministry showed the violation of licensing and labelling provisions under Indian Drugs and Cosmetics Act, 1940. Ingredients of the formulations do not conform to the listing on the label. It needs to be ascertained whether or not animal or even human material was used in Ramdev's medicines as alleged.

Neglected by public attention is the manner in which the food and drug agencies of the state governments award licenses to such companies.

'What law have I violated? There are no quality checks in Indian ayurveda. It all depends on faith. Divya Yog pharmacy has both ISO 9001 and good manufacturing pratices (GMP) certifications,' says Ramdev in an interview reacting to the charges levelled by Karat. If the health ministry could find discrepancies in Divya Yog pharmacy's products, then how come that it has ISO and GMP certifications? Do the licensing authorities actually follow the conditions for the grant of license laid down by the government of India?

'The ayurvedic manufacturing units are granted license by the government of the state in which they are set up only after they fulfill all the conditions laid down under the Indian Drugs and Cosmetics Act, 1940,' says Vijay Garg, drug inspector for ayurveda, Delhi.

'But the state government only gives them the GMP certification. The state government is not concerned with ISO certifications. They are granted by international private organisations,' Garg adds.

There appears to be carelessness in the grant and cancelling of ayurvedic manufacturing units and lapses in quality control checks. Expenditure incurred on this count has not been justified. A report of the comptroller and auditor general (CAG) states that of 7,849 ayurvedic medicine-manufacturing units in India, only 707 (10 per cent) has obtained the mandatory GMP certificate. Despite this, state governments have not cancelled the licenses of non-GMP manufacturers.

On quality control checks in Indian ayurveda, Garg says, 'Of course quality control checks are carried out. The directorate of Indian system of medicines and homeopathy (ISM and H) under the drug control department of India is responsible for the quality control checks in these units. Checks are carried out twice a year, on or without complaints.'

But the CAG report says that as far as the quality control is concerned, it stands ineffective as there is no standardisation in respect to compound formulations (mixture of many ingredients) in ayurveda and siddha, and a nominal check just twice a year might not be enough.

Despite Rs 7.85 crore spent on expert panels between 2000 and 2005 pharmacopoeia standards for ayurvedic and unani drugs still remain to be developed. The health ministry identified 921 formulations, including 427 single and 494 compound drugs, for development of standards and also awarded work to 32 labs in 1997-98 but no standards have been set yet for compound drugs.

Admitting that there was a need for stronger regulation of the ayurveda sector, union health minister, A Ramadoss, told a news channel that the government is investing Rs 120 crore in a programme to 'scientifically validate' the procedure for the manufacture of ayurvedic medicines.