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August 2009  
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Approaching AD Syringes

Union Health Ministry's mandate to switch over to Auto-Disposable (AD) syringes is just not enough to boost the AD market. Sonal Vij tells you why

The Union Health Ministry had mandated April 30, 2009 as the last date on which the public health system is supposed to switch over from conventional disposable syringes to Auto-Disposable syringes (AD) which become dysfunctional after single use. According to a mandate signed late last year, all central government hospitals under CGHS will use only AD syringes. In addition, an advisory was sent to all state health ministers and various Governments to change over to AD syringes in a year's time. Individual letters were sent to each state.

Speaking on the market potential, Murali Nair Partner Advisory Services, Ernst and Young says, "In case CGHS hospitals implement their efforts of only using AD syringes, then the market size of AD syringes will go approximately up to 516 million units (at an estimated average use of five syringes per beneficiary)."

The Demand

Demand for AD syringes picked up after WHO-UNICEF-UNFPA and Red Cross jointly issued a policy mandate in 1999 that with effect from January 2001 UN bodies will procure and provide only AD syringes for immunisation and urged all UN member countries to similarly do so by 2003. "At the last Safe Injection Global Network (SIGN) meeting of WHO in October, held last year in Moscow, it was proposed to extend this policy for curative injections in a phased manner, as the problem was more evident for curative or therapeutic injections. This account for over 90 per cent of the injections in the developing world including India," says Rajiv Nath, Joint Medical Director, HMD.

There are about 40-odd syringe manufacturers in India. Out of this, the biggest syringe manufacturer is Delhi-based HMD, which has a market share of 60-65 per cent. HMD manufactures about 1.5-2 billion syringes every year, from which, five to 20 per cent are AD syringes, depending upon the demand.

The Big Problem

The entire AD market is driven only from the immunisation side, since it is mandatory for all the WHO -funded programmes to make use of this. But the real problem lies on the curative side. Of the curative side, the public sector accounts for only 20 per cent of the size. Of this 20 per cent, there is state as well as the Central Government hospitals. The mandate is passed only for the Central Government hospitals, which will not drive the demand to a great extent.

New Kids

"The central Government hospitals form just a small portion of the of the three billion syringe units market"

- Ram Sharma
Managing Director
BD India

"You may have a car, but not know how to drive it? It is the same case with AD syringes"



- Rajiv Nath

Joint Medical Director
HMD

However, the manufacturers are not taking a chance by underestimating the market. Reportedly, Haryana-based Lifelong Miditech, whose brand of 'Safeway' syringes enjoys seven to eight per cent of market share, currently do not make AD syringes. But now the company plans to set-up a unit in Manesar to make AD syringes and also manufacture safety syringes for the US and European market later this year. "Our first priority is India. We will launch syringes in India by end of this year," says an official from the company (requesting anonymity).

Also, Ahmedabad-based Tiger Surgicals plans to launch the world's cheapest AD syringes. "We have our 'own design' which reduces the cost of manufacturing. We have started supplying our syringes to some Delhi hospitals now. The company targets to manufacture five lakh AD syringes per day in the future," says JK Patel, Managing Director, Tiger Surgicals. Previously, the company used to only export the syringes, but now they are also eyeing on tenders in the public sector. Soon, the company will manufacture a combination of safety and AD syringes.

Also, Delhi-based Veeky Surgicals Private Limited, with a market share of five per cent, will soon enter collaboration with a company abroad to manufacture Re-Use Prevention (RUP) syringe. Says VK Khemka, MD, Veeky Surgicals, "Some designs of AD syringes allow re-use of needles, and we will concentrate on safety syringes. That will be our focus."

In Tamil Nadu, Hindustan Latex Ltd (HLL), a Government of India enterprise, is also setting up a manufacturing unit for AD syringes. Quite contrary to the fact that Tamil Nadu hasn't placed any orders for AD syringes. Dr KRS Krishnan, Executive Director, HLL, comments, "The location is irrelevant, but, we want to get into this market. Hopefully, in a year and a half, we will launch the product. The product will be marketed under the name B-sure." The company had a tie-up with BD but now it is derailed and the company is looking for prospective partners. The company plans to manufacture affordable RUP syringes. "We want to remove the myth that RUP syringes are expensive," he affirms. Even BD India plans to start dealing in AD syringes by the end of this year.

The Unexplored Territory

The market potential is huge and most manufacturers feel that this is just a small tip of the iceberg. Ram Sharma, Managing Director, BD India, says, "The central Government hospitals form just a small portion of the of the three billion syringe units market."

The capacity of manufacturing conventional syringes in India is at around 1,000 million units per month, whereas the capacity for AD syringes is almost nil incurring huge foreign exchange on imports. Many experts feel that it will be a monopoly of one or two companies in India, which is unfair to all other manufacturers. It will also attract the Monopoly of Restricted Trade Practice (MRTP) Act.

State Watch
  • It is understood that the Delhi Government hospitals are definitely much faster in implementing this mandate.
  • Tamil Nadu hasn't placed any order. The state still continues to use glass syringes. Also, one of the other premier hospitals in the country, PGI Chandigarh is also not doing anything about it. No hospital in Puducherry has placed orders as yet.
  • The states, which have placed orders are Maharashtra, Karnataka, Andhra Pradesh, Uttar Pradesh and Bihar.
  • Karnataka is one state, which has implemented AD syringes in all state and central Government hospitals for the last few years.
  • Gujarat has also decided to use AD syringes after the Hepatitis outbreak in the Sabarkantha district of Gujarat that claimed nearly 83 lives. The state Government has decided to use AD syringes for vaccination instead of the standard disposable syringes henceforth.

China is Here Too!

With growing popularity of AD syringes in India, the import market too will be affected. Industry sources say that many smaller players are importing syringes from the world's largest factory-China, sterilising them and re-packaging them to sell. "I feel this is alright as long as the manufacturers are complying with the regulations," says Khemka, who is also the Joint Secretary of All India Syringe Manufacturers Association.

Many experts are against this practice because many Government tenders today give concessions to indigenous manufacturers. These manufacturers who import syringes and pack them in India too reap these benefits.

These players import the syringes but stamp it as 'Made in India' and reap benefits like an indigenous manufacturer without investing in patents and machinery. The design for AD syringes is patented and one has to pay a lot to buy the rights for the patent. From a manufacturing standpoint it is one more additional cost. Therefore, to save costs nearly two to three syringe manufacturers are importing syringes from China in bulk, sterilising them and then reselling them instead of buying the patent.

Considering this scenario, the association is demanding that companies who import syringes from China and supply the syringes in Indian markets should not be labelled as 'manufacturers'.


Injections, as opposed to being disposed, lying with other injections






BD India plans to start dealing in AD syringes by the end of 2009

Child playing with an injection assuming it to be a toy



Tiger Surgicals plans to launch the world's cheapest AD syringes

Tackling Cost Issues

The biggest challenge for the manufacturers`` as well as the buyers is the cost. "In Government tenders, the traditional 2ml syringe sells for 90 paise (without the needle). While an AD syringe costs Rs 1.60," says Khemka.

Industry experts like Sharma feel that policy changes like making it mandatory to use AD syringes in the entire country, will boost manufacturing and bring in more competition in the market. Thereafter, prices of AD syringes will be as much as that of a normal disposable syringe.

At the same time, All India Syringe Manufacturers Association is working on bringing down the price of disposable syringes. "The price of a disposable syringe in the wholesale market is Rs 1.25, however, in retail the MRP is Rs 5. We are trying to bring down this price so that there is lesser re-use of these syringes," says Khemar. He informed that the association is planning to reduce the MRP to Rs 3.

But the good news is that with new players entering this market, there are cheaper AD syringes available as well. An industry source says, "ADs were sold at Rs 5.50 each (because of monopoly). Now, we sell the same syringe for Rs 1.50. With indigenous players like us, there won't be monopoly anymore." The prices will therefore automatically come down.

Need a Desperate Change
  • Hard to believe, but almost two thirds of the injections are administered in an unsafe manner in our country. Out of all injections administered in India, one third carry a potential risk of transmitting blood borne virus.
  • Unsafe injections are the highest at immunisation clinics followed by Government health facilities and private health facilities. These are some of the key findings of a study conducted by the IndiaCLEN Programme Evaluation Network on behalf of the Ministry of Health, Government of India and World Bank, entitled Assessment of Injection Practices in India, in 2002-2005.
  • In the areas of waste disposal too, disposal of plastic syringes and disposable needles was observed at 61.3 per cent of the health facilities and was found to be least at immunisation clinics (50.9 per cent).
  • Satisfactory terminal disposal of injection related wastes was observed in less than half the health facilities (44.8 per cent) and was found to be the least at private health facilities (41.5 per cent).
  • Surprisingly, in rural areas health facility levels of plastic syringe disposal were better in urban areas (69.6 per cent) of the country as compared to their rural counterparts (57.9 per cent) in all sectors. Similarly, satisfactory terminal disposal was more in urban health facilities (51.2 per cent) as compared to that of health facilities in rural areas (42.2 per cent).
  • Some startling facts from WHO reveal that more than 50 per cent of all injections in the developing world are unsafe, which would mean that they are performed with re-used or un-sterile equipment.
  • Every year, due to unsafe injections, WHO estimates that there are 2,30,000 HIV infections, 1,000,000 Hepatitis C infections, 21,000,000 Hepatitis B infections and 1,300,000 deaths. Says Marc Koska , Founder, Safepoint Trust, which advocates the use of AD syringes in developing countries, "Another big impediment that we foresee is that worldwide, immunisation accounts for just five per cent of all injections and most immunisation programmes use AD syringes."

Need for Education

This market is mainly raw and untapped simply due to ignorance and unawareness about the dangers of re-using syringes. Once the demand rises, obviously the manufacturers will be compelled to make them. Hence, sincere efforts have to be taken to educate at both ends— the patients as well as the users. "You may have a car but not know how to drive it? Same is the case with AD syringes," opines Nath.

There are also certain designs of AD syringes that leave breakage of needle to the doctor. If not properly disposed, they can harm the clinician or the garbage collectors. "If hospitals think that if they are buying AD syringes, they don't need proper waste disposal, then they are wrong and if they think that they are doing proper waste disposal and not buy AD syringes, then too they are wrong," says Nath.

Moreover, most nurses are used to pumping syringes before using them. When they do this to some AD syringes, the syringe gets spoilt and cannot be used. However, the other designs of AD syringes leave the disposal of syringes to the doctor, thus, defeating the entire purpose. So, the nurses have to be trained how to use it.

Into the Future

Re-use prevention syringes will be the next big thing in the future. The needle will automatically go inside the pump. This syringe will be much safer both for the patient as well as the medical practitioner. The disposal will also be safer. This will be particularly useful to avoid blood-borne infections. Organisations like Safepoint Trust which informs the public as well as the medical practitioners about the importance of AD syringes also help to drive the market.

Though, CGHS hospitals have been asked to shift to AD syringes, even their implementation is still slow. The need lies in tapping the small private clinics in rural India. After all, there are 700 million people out there depending on the rural hospitals and clinics for their healthcare. This will really reduce the number of infections in the country and reduce some healthcare burden on existing facilities. Indeed a long way to go!

sonal.vij@expressindia.com

 


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