Serious efforts are needed for the growth and development of Ayush industry, especially Ayurveda in Andhra Pradesh. Though the ayurvedic drug manufacturing units including a number of big players have been seeking the support of the state government for the unbridled growth of the industry, the government has given a short shrift to their pleas upto this time.
Manufacturers as well as traders in the ayurvedic industry who are critical of the government apathy towards this sector says that Andhra Pradesh would have been the numero uno state in India in the manufacture and sale of ayurvedic products , had the government heeded to their pleas.
Owing to the lack of government support, the ayurveda manufacturing units could not compete in the Indian as well as in the international markets, said a member of the newly floated Confederation of Ayurvedic Industries in AP (CAI).
The office-bearers of the association urged the government to come forward with new schemes and policies to support the withering units. They took umbrage at the fact that the government has no confidence in the manufacturing units in the state. While the previous state government had set aside funds for irrigation, precious little was done for healthcare system, they lamented
“We want to compete in the domestic markets and also in the international markets, but we don’t have any source or facility to grow upto that level. While in other states , the governments are helping the ISM industry, in AP, there is no support from the government. They are not doing anything for the growth of the Ayush industry. We want facilities and technical support to improve the prospects in the domestic market as well as on the exports front, said Mughesh Singhania, executive committee member of the CAI and the Director of Amrita Drugs, Hyderabad.
According to CAI, the state government has neither a policy nor doing anything for the growth of Indian system of medicine in Andhra Pradesh. The state authorities are not providing any infrastructure facilities for establishing new units or expanding the existing ones or providing any export facilities for the local industry. There are no awareness programmes or workshops on GMP or on QC or exhibitions or melas by the government. The government is not purchasing even a small quantity of medicine from the local units, said Mughesh. Awareness about ayurveda and other Indian System of Medicines was very poor among the people of the state, he added.
Even though there are hundreds of manufacturing units with GMP facilities, only a very few of them are engaged in overseas business. The biggest players are Venkateshwara Ayurvedic Nilayam in West Godavari, Indian medicine industries in Vijayawada, Syndi Pharma at Kavali in Nellore District, Amrita Drugs in Hyderabad, Fours Laboratory in Hyderabad, Jain Ayurvedic Pharmacy in Hyderabad, and Nuzen Herbal Private Limited in Hyderabad. These companies seek the services of traditional manufacturers of bhasma from Ramachandrapuram near Rajahmundry. At present all the big companies are using only 20 per cent of their production capacity because of poor sales. There is no co-operative sector like IMPCOPS in Tamil Nadu. Even the AP government is purchasing drugs from IMPCOPS in Tamil Nadu.
All the units are suffering in many ways. But the most crucial problem they are facing is the lack of a well established common sample testing laboratory. There is just one sample testing laboratory under government, but it is not fully catered to meet the needs of all the companies or to test all the samples collected by the drug inspectors. So the manufactures have to depend on private laboratories which charge huge amounts for testing.
“Though the companies carry out initial tests, following batches are not tested. Only for getting licence, the units test their samples”, one doctor-cum-manufacturer said. Whereas, some companies have in-house testing facilities, the small -scale units are unable to compete with the big players.
Giving an overview of the situation, the ayurvedic manufacturers said though the Ayush department had given Rs one crore for setting up a testing lab in the government Ayurvedic College at Erregada and the lab was inaugurated in 2006, no expert technical person was appointed there to run it.
According to a GMP consultant “no test is being done for heavy metal or for the microbial contamination. The licensed pharmacies cannot utilize the government lab. The only other source for them is the private labs. There are three private labs working in the state capital. They are Sipra Laboratories, IICT and Varun Herbals. Out of this one lab has downed the shutters recently “.
In the government labs, there is no quality control division and chemists are not even aware of ayurvedic production techniques. There is one manufacturing unit under the control of the government which is situated at Kattedan in Hyderabad. But the unit also has some problems and so it is not functioning properly. Only a very few medicines are manufactured there, he added.
The industry’s other challenges include non-availability of certified medicines. The duty of the National Medicinal Plant Board (NMPB) is to procure and standardize medicinal herbs and distribute them to the industrial units. But in AP, the NMPB has no accurate data about herbs. The units which have own quality control lab are standardizing their own extracts. Other units are plainly manufacturing the formulations with the available raw drugs, he said.
The Confederation of Ayurvedic Industries has demanded that the government should insist the dealers of raw materials to sell only the certified and standardized herbs as NMPB is not giving any support.
In AP there are 550 government Ayurvedic dispensaries and six H.Q hospitals where IP treatment is available. Since the pharmacies in these hospitals are facing shortage of medicines, the patients are able to get only very few medicines. Each dispensary is getting medicines worth Rs.15,000 and also in a phased manner. The manufacturers claim that Andhra Pradesh will be a safe haven for developing Indian System of Medicines and a centre for raw drugs if incentives are provided for the industry and cultivators.
The situation in the academic sector is also no way better. Very poor standards are maintained in the Ayurvedic colleges, both in government and private sectors. There are three government Ayurvedic medical colleges, one each in Hyderabad, Warangal and Vijayawada. The four private medical colleges are located at Tirupati, Warangal, Karim Nagar and Sanghareddy. All these colleges do not follow all the norms of Central Council of Indian Medicine in running courses.
Though CCIM has specified that there should be 14 departments in a medical college, in the government colleges in AP all these departments are not functioning well and the facilities are poor. They comply with only 75 per cent of the CCIM norms. Likewise the hospitals attached with medical colleges are also lacking proper facilities, said Dr Sridhar Anishetty, vice-president, Ixoreal Biomed Pvt Ltd.
Besides shortage of raw materials, the available raw drugs are not found to be authentic. Apart from this, adulteration is also prevalent. The manufacturing units in AP are getting raw materials from other states. Since they are in powder form , they cannot be identified, said Dr Sridhar.
Though gynecology, pediatrics, surgery and ENT are part of BAMS syllabus, they are not taught in most of the colleges including those in government sector. Because of the poor standards of the academic institutions, the CCIM did not recognize the medical colleges (government and private) to conduct BAMS course last year. Though later these colleges approached the Department of Ayush for special permission, only the government colleges received special permission to conduct courses. According to CCIM the private medical colleges in AP are facing shortage of facilities and expert staff.
In respect of overseas marketing, they said there is only a very little export of formulations. At the same time some companies are exporting extracts and raw herbs. The export of raw drugs has led to price escalation in the local market. While countries, which are getting herbs from India, are doing research, It has impacted research activities in the state. Even though, Ayurvedic sector is booming in AP, research activities are almost nil.
Apart from this, regulatory department is also slack in in enforcing law. The state has 23 districts covering Telengana and Rayalaseema regions, but there are only three drug inspectors for the whole of the state. There are about 550 GMP certified companies and a huge number of pharmacy shops. Since all these are monitored just by three drug inspectors, the department is unable to enforce the law properly. In most of the companies, the GMP facilities are poor. Documentation in GMP is not checked due to the lack of drug inspectors. Once a drug inspector from Hyderabad goes to a far off place, his office will remain closed till he returns. Most of the times medical officers who are appointed as drug Inspectors are not much aware of Pharmacy and Drugs and Cosmetics Act.
The drug inspectors are selected on deputation from medical officers in the Ayush hospitals for a period of three years, and on completion of the term they are sent back. This makes the licensing system difficult as they do not know the Drugs & Cosmetic Act 1945 or the rules made later on. By the time have a grasp of the rules and regulations, they would be transferred. When this issue was raised before the additional director in the department, he said that the government would recruit a separate group of drug inspectors exclusively for regulatory work soon. But selection would be from BAMS graduates only. He said the department had requested the state government to create a post of drug controller exclusively for ISM department. Currently, the department is functioning under a commissioner.
According to a senior doctor and a GMP expert, the drug inspectors are not well versed with the Act or Rules or the Amendments, and the copies are not filed properly. They follow the old books of the Act and do not refer the recent edition of the D&C Act. He explained that one drug inspector has to check an average of 166 manufacturing units, their additional products, their lab tests and GMP documents , that also only a very few companies maintain. These inspectors who are seated in the head quarters at Hyderabad are not even provided with inspecting vehicles,he bemoaned.
One of the two GMP consultants who along with the concerned area drug inspector to inspect the units for issuance of certificates, pointed out that from 2008 onwards, the services of the consultants have not been utilized for inspections. They were not given training in Schedule T or in inspection methodologies or in modalities. No pharmacovigilance committee is formed in AP. Even in this modern age there is no digitalized system in the department. There is only one drug inspector for homeopathy and two for Unani in the whole state , he rued
A major lacuna on the regulatory side is that the Ayush department in AP is functioning without an exclusive Drug Controller. It lacks sufficient staff and technical personnel. There is no timely inspection or checking either in the company or in the trade shop. All inspections are held only for issuing the licenses, afterwards nobody is bothered about the industry. “Whether the drug is spurious or substandard or adulterated, nobody is going to look into. The manufacturers have no complaints, the traders have no complaints, and the regulatory officials have no complaints. Everybody says everything goes smoothly, so all are happy”, a pharmacist-cum-trader said.
Under NRHM scheme, the doctors are working on contract basis in the club hospitals. These hospitals are also facing staff shortage. While the doctors only make occasionally visits here, medicines available in these hospitals are not of standard quality. There are 400 ayurveda hospitals under NRHM and 300 Homoeo and Unani hospitals, the people in the industry said.
There are three associations for the manufacture of ayurvedic medicines, each centered at Vijayawada, Rajahmundry and Hyderabad. These three associations came together in 2010 to form the Confederation of Ayurvedic Industries, whose head quarter is at Hyderabad.