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Medical Abortion in India: Role of Chemists and Providers

Medical abortion, approved in India in 2002, is emerging as an alternative to surgical procedure for terminating early pregnancy and offers a window of opportunity to expand women's access to safe and effective abortion. A study undertaken of chemists and providers points to some of the challenges such as limited awareness of the appropriate regimen, protocol and likely side effects, the cost to clients, resistance of providers of surgical abortion and the need for adequate backup facilities. All these have to be addressed in order to make medical abortion available widely.

Medical Abortion in India: Role of Chemists and Providers

Leela Visaria, Alka Barua, Ramkrishna Mistry

centres. How ever, adequate backup facilities, and training of existing staff in screening, monitoring, evaluation of the status of abortion, are very essential before the use of medical abortion is promoted widely.

Following the approval of medical abortion in 2002, four Indian pharmaceutical

Medical abortion, approved in India in 2002, is emerging as an alternative to surgical procedure for terminating early pregnancy and offers a window of opportunity to expand women’s access to safe and effective abortion. A study undertaken of chemists and providers points to some of the challenges such as limited awareness of the appropriate regimen, protocol and likely side effects, the cost to clients, resistance of providers of surgical abortion and the need for adequate backup facilities. All these have to be addressed in order to make medical abortion available widely.

Leela Visaria (visaria@vsnl.com) is with the Gujarat Institute of Development Research, Ahmedabad; Alka Barua (alki75@hotmail.com) is with Foundation for Research in Health Systems, Ahmedabad; and Ramkrishna Mistry (ramkrishna.mistry@gmail.com) is with Entrepreneurship Development Institute of India, Ahmedabad.

Economic & Political Weekly

EPW
september 6, 2008

T
hough legal since 1972, access to safe abortion in India continues to be hindered by poor infrastructure and trained personnel and social stigma. With the approval by the Drug Controller of India in 2002, medical abortion has been included in the basket of abortion methods, making termination of unwanted early pregnancies easy, safe and effective. Medical abortion is a non-surgical intervention and is based on a tested regimen of a combination of two drugs, Mifepristone (also known as RU-486) and Misoprostol. Mifepristone blocks progesterone hormone, necessary to sustain pregnancy. When the hormone is blocked, the lining of the uterus breaks down, the cervix softens and bleeding begins [Jones and Henshaw 2002]. Within a few days after taking Mifepristone, Misoprostol is administered either orally or vaginally to induce uterine contractions and empty the products of conception [Harvey et al 2002].

Prior to the approval of medical abortion to end pregnancy of up to 49 days (or seven weeks) gestation, three studies were conducted in urban and rural locations in I ndia between 1990 and 1998 to assess the acceptability, safety, efficacy and feasibility of the regimen [Coyaji 2000]. The first study was a part of a three-country study; the other two countries being China and Cuba [Winicoff et al 1997]. The results showed that the prerequisite of frequent institutional contacts did not affect the choice; 95 to 99 per cent of the women were able to adhere to the protocol of three visits and the method was effective, acceptable and safe. The side effects r eported were within the expected range and could be managed at home. The study concluded that medical abortion can be made available in India’s rural areas if community is made aware about the regimen, and likely side effects by the grassroots level workers and/or functionaries at the government health companies began marketing the drugs to gynaecologists nationwide. The company web sites noted that the drugs are to be administered only in a clinic/hospital setting, by or under the supervision of a gynaecologist, who is able to assess the gestational age of the embryo and diagnose ectopic pregnancy.1 Post-approval studies in Bihar and Maharashtra validated successful termination in 93 to 96 per cent of women with minimal reporting of side effects such as nausea, vomiting and abdominal pain [Gupta 2004; Mundle et al 2007].

Given the potential of the method to provide expanded choice, and, therefore widespread demand and use amongst women, it was important to understand the reach of the method in terms of marketing strategies of the pharmaceutical companies and challenges faced by the I ndian medical community. We therefore undertook an exploratory qualitative study in 2004 in the Ahmedabad urban area with the support of Ipas, New Delhi, and interviewed gynaecologists to understand their perspective on medical abortion and the chemists to understand marketing strategies and drug distribution.

1 Findings

The following are the main findings of the survey.

1.1 Chemists

Using snowballing technique, 13 chemists were interviewed.2 Two of the chemist shops were small with just one person, seven were mid-sized with two-three a ttendants and four were large with more than three persons attending the counter. These shops were dispersed throughout the city of Ahmedabad and were located in poor as well as in the well-off neighbourhoods. Some were in the vicinity of hospitals or clinics of gynaecologists.

Availability of Drugs: The pharmaceutical companies provide medical abortion drugs directly to the chemists to stock, but getting information related to the availability of drugs was tough. Despite assuring them of confidentiality, some of them were not willing to provide information on all questions put to them. For example, they were not forthcoming about the stock of drugs or selling these directly to clients because of the fear of law e nforcement agencies.

Based on the information provided, the list of available medical abortion drugs, their dose and cost in the market was drawn up (see table below).

Table: Medical Abortion Drugs Available with Chemists in Ahmedabad

Drugs and Pharmaceutical Dosage as MRP
Company Reported by Rs#
Chemists
Mifepristone Tablets
1 Mifegest (Zydus Alidac) 1 325.50
2 Mifeprine (Sun Pharma) 1 325.50
3 MT Pill (Cipla)* 3 930.00
4 Mifyron (German Remedies) 1 325.00
Misoprostol Tablets
1 Cytolog 100 (Zydus Alicac) 4 31.00
2 Cytolog 200 (Zydus Alidac) 4 60.00
3 Zitotec 200 (Sun Pharma) 2 30.50
4 Misoprost 100 (Cipla) 4 31.00
5 Misoprost 200 (Cipla) 4 60.00
6 Misogon 4 60.00

* The Cipla tablets are sold in a pack of three. # The price of Mifepristone has, since the study, come down to Rs 180 or so.

However, not all chemists carried all drugs. Two chemists reported that they stocked only pills meant for regularising menstrual periods. According to them these tablets were commonly used for abortion as well and they believed that although the success rate of these in terminating pregnancy was quite low with a likelihood of serious side effects, they sold them nonetheless because clients specifically asked for them. One mentioned that in spite of being approached by a stockist to keep the tablets, he did not do so as he believed that there was little demand for such high cost drugs in his area.

Of the 13 chemists interviewed, 11 reported that they stocked Mifepristone and Misoprostol. Interestingly, eight of them were approached directly by the pharmaceutical companies or stocked on their own in response to the demand of their regular clients who sometimes approached them without gynaecologists’ prescription. The remaining three chemists stocked on request from the neighbourhood gynaecologists.

The patients could thus easily buy the drugs and the gynaecologists did not have to recover drug cost from women and handle payment-r elated issues.

The stockists who normally supplied them various other drugs supplied medical abortion drugs. Factors such as sales incentives, schemes and commission

o ffered by the pharmaceutical companies determined which brand name to stock. On certain products, the chemists/retailers received commission up to 20 per cent. However, they were reluctant to stock drugs of little known companies even when they offered good commission because of the fear that the clients might not either be prescribed these drugs or might not themselves prefer them.

Supply Channel: The chemists stocked both Mifepristone and Misoprostol by their brand names and procured them through the distribution channel. Illustrative depiction of the supply channel as described by a distributor during his interview is provided in Figure 1.

A pharmaceutical company appoints a carrying and forwarding agent (C&F agent, also known as a consignee) for each state except for the parent state, where its manufacturing units are located. The C & F agent is given a commission of 3-4 per cent for storing medicines at his warehouse. While his role is largely limited to storing the medicines (and other products), this arrangement saves the company 4 per cent central excise tax. From his warehouse the products are sent to the stockists as per their requisition. The stockist gets a commission of about 8-10 per cent, depending on each company’s policy. In a city there could be several stockists not necessarily catering to any specific geographical area. They supply medicines to different retail chemists in the city.

Occasionally there are sub-stockists who procure goods from the main stockists and then pass them to the retailers. A sub-stockist generally earns commission of about 5-6 per cent. The retail chemist is the last link in the entire distribution channel. He earns 7-10 per cent commission on the maximum retail price (MRP) printed on the drugs that is charged to the client. However, the pharmaceutical companies occasionally offer special discounts on certain products, or some free drugs depending on the quantum of the order of the stockists and retailers, to promote their products. The incentives and commission vary between products and companies.

Demand and Supply: Eight of the 13 chemists indicated that in a month on an average anywhere between one and four clients come for the abortion pills. The remaining five sold the drugs to more than eight clients in a month. The location of the medical shop near practising gynaecologists and the socio-economic status of people in the area determined the demand.

When asked if the sale of medical abortion drugs was only on prescription, initial reaction of all the chemists was that prescription from a medical doctor was a prerequisite for sale. However, on probing, many of them admitted that they do provide prescription drugs to their “regular or known” clients. Almost half of them (7/13) said that more than 50 per cent of their clients come without prescription. Women

Figure 1: Distribution Channel of Pharmaceutical Products

Pharmaceutical Company Carrying and Forwarding Agent (State Level) Stockist (City/Area Level) Chemist (Retailer) Sub-Stockist (Sometimes)

who do not abort even after trying some home remedies approach chemists, who in turn advise their regular clients to try a concoction of ground black pepper boiled with tea before taking any drugs.

Five of the 13 chemists reported that some clients who come without a medical prescription ask for medical abortion drugs by either their brand names or generic names. The remaining eight chemists indicated that clients without prescription sought their help on medication for terminating pregnancy. However, three of these eight chemists clarified that they never recommended any drugs as it could create

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problem for them. Five of them reported that in such a situation they gave only a yurvedic medicines to the clients since these do not have many side effects. Only four chemists disclosed that they do r ecommend medical abortion drugs to their clients when their advice is sought and also sell them. In fact, they do not even advise their clients to consult a g ynaecologist before starting the regimen.

Information Given to Clients: By and large, most of the chemists had no knowledge about the regimen of medical abortion drugs, the gestation period up to which they are recommended or are perceived to work effectively.3 They believed their job entailed sale of drugs based on either what the clients asked for or as per the prescription of a gynaecologist. None of them had read the literature enclosed with the drugs. It was not surprising therefore that they did not give any oral information or shared the literature with their clients. They expected the clients who sought the drugs directly from them to learn about the dosage, the regimen, possible side effects, etc, from other sources. A study carried out in Bihar and Jharkhand states also reported that the chemists did not share the drug information with the clients [Ganatra et al 2005].

Only two chemists were aware about the recommended combination of Mifepristone and Misoprostol for safe and complete abortion and of the likely side effects. To clients without prescription these two advised about the measures to be taken in the event of heavy bleeding, severe a bdominal pain, etc. The rest of the 11 chemists assumed that either the clients were aware, especially when they asked for the drugs by the brand name or that they had been informed by the doctors they consulted. In fact, when clients asked for measure to be taken in the event of unsuccessful abortion after taking the drugs, only four suggested that they should consult a doctor or go in for surgical abortion. One chemist recommended two tablets of Cytolog 200 or Zitotec 200 (Misoprostol) to his clients.

Nearly half the chemists did not know whether the medical abortion drugs they sold brought about the desired result u nless the clients reported the outcome.

Economic & Political Weekly

EPW
september 6, 2008

Many a time the clients who bought the drugs did not ever return to the shops.

2 Providers

We interviewed 10 service providers in and around Ahmedabad city. Two gynaecologists whose names featured as providers of medical abortion in an earlier study were first contacted [Barua 2004]. They in turn provided names and contact addres ses of other providers (after seeking their c onsent) of medical abortion. The usual ethical considerations guided the interviews.

Of the 10 providers, one worked in a public hospital and the remaining nine were private practitioners. Except for the provider from the government tertiary care hospital and two private practitioners, the remaining did not have a legally recognised facility to conduct medical termination of pregnancy (MTP). However, they did perform surgical abortions and their caseload ranged from 1 to 10 per week. Three of the service providers were male; the rest were women. All the providers were in early or mid-30s and were qualified gynaecologists. Except for two, all others had practice of more than five years. Only one provider practised in the adjoining rural area.

Source of Information: These providers had come to know about medical abortion drugs and regimen mainly from the medical representatives of pharmaceutical companies who are generally the major source of information on the new products introduced in the market by their companies. The pharmaceutical companies also promoted these products through workshops for medical practitioners. As one provider said:

I came to know about the drugs [abortion pills] at a workshop held in Nadiad. The workshop was arranged by Cipla pharmaceuticals.

Six providers mentioned that medical abortion being current and controversial featured often in the obstetric and gynaecology journals. Five of them said that they learnt about it from the conferences arranged by the Federation of Obstetric and Gynaecological Societies of India (FOGSI), various local chapters of their a ssociations and from the literature made available by the pharmaceutical companies producing the drugs.

Only the provider from the government tertiary hospital was aware about the drugs being available with the local chemists. Others were categorical that the drugs were not available with the local chemists. According to them, the drugs are supplied directly by the pharmaceutical companies to the gynaecologists. To quote one,

As far as I know none of the chemists in my

neighbourhood sell these. They are not sup

posed to sell these as the prescription of

these tablets is under strict legal stipula

tions. They are not over the counter drugs to

be available freely. They need gynaeco

logist’s prescription. Otherwise, there will be

rampant misuse. The consequences will be

disastrous; there will be manifold increase

in complications and maternal mortality.

Except for the one rural practitioner, all the others had the knowledge that medical abortion drugs were approved by the Drug Controller of India in 2002. The rural practitioner who had been using the drugs for more than two years believed that these had been legal since a long time.

Supply and Cost of Drugs: Most of the service providers indicated that they received the supply of drugs directly from the medical representatives of pharmaceutical companies and not from the stockists. Only one practitioner received free samples from a pharmaceutical company. The provider from government tertiary hospital indicated that her clients purchased the drugs from local chemists.

Drugs were supplied by three pharmaceutical companies – Zydus Adilac, Sun Pharma and Cipla. The rural provider who had been administering the medical abortion tablets for a few years, earlier used to provide “Chinese drugs”, but once the I ndian made drugs were available, she switched over. However, she felt that the Chinese drugs were of better quality and more efficacious though more costly.

The provider’s choice of drugs of a particular pharmaceutical company depended on a range of factors. If the supplier of a company was a close relative of the provider and ensured regular supply that company was preferred. Given the little variation in the price of the drugs of different companies, the cost per se was not a consideration but the commission provided did influence the choice.

Service providers claimed that cost of medical abortion to the clients is high if the recommended protocol that includes the use of ultrasound is followed. The total estimated cost of medical abortion including consulting charges of the provider and the three ultrasound graphics worked out to be about Rs 1,200, which is a potential deterrent for many clients. In fact, seven out of 10 service providers believed that if a woman were to seek surgical abortion in a government facility, the total cost would be significantly lower than that of medical abortion. Interestingly, three of the 10 service providers had devised ways of keeping the cost of medical abortion on par with surgical abortion either by doing away with at least one each of ultrasound examination and clinic visit or getting the drugs at a discount and passing on some of the benefit to their clients.

Method Choice: Providers claimed that they informed their clients about various methods but did not insist on use of any specific one. However, while offering the choice to the clients or recommending the method, they were guided by factors such as cost and client’s ability to follow the i nstructions and the regimen. According to one provider:

I use pills in selective cases – for those who are educated, can afford the cost and will comply with the follow up regime.

Three service providers felt that allowing women the method choice is not always practical because not all methods are suitable to everyone. One provider explained the process that she follows.

I strongly believe in cafeteria approach. But I equally strongly believe that not all methods are suitable to everyone. So, I do tell the woman and her partner about all the abortion methods, their advantages and disadvantages, cost, and side effects using slide shows, educational material and couple counselling. Then I ask them about their choice. After discussing whether the selected method is suitable to the acceptor, I guide the couple and most accept my advice. I also find out whether the couple plans to have any more children in future. Only if I am convinced that the woman is suitable for medical abortion, do I prescribe the tablets.

According to most providers, women preferred medical abortion because it is an effective, non-invasive technique not requiring any anaesthesia or hospital stay. However, according to one provider, religious belief of the clients also influenced the choice of the method; her large Jain clientele did not prefer surgical abortion and therefore medical abortion was the predominant method available in her centre. Eight of the 10 providers mentioned that some women first tried Ayurvedic preparations or morning-after pills either on their own or prescribed by their general practitioners before approaching them.

Regimen and Protocol: Almost all the providers were aware about the recommended protocol for medical abortion drugs. The legal stipulations prompted majority (8/10) to confirm gestational age and rule out ectopic pregnancy by clinical and ultrasound examination. After that they administered the Mifepristone tablet in the clinic. They then sent the woman home with Misoprostol tablets and the a dvice to take those 48 hours later. The women were advised to come for first follow-up visit after seven days and second follow-up after two weeks. One service provider preferred to give the Mifepristone tablets on a Friday to be followed by Misoprostol on a Sunday, as it was easier for the client to get in touch with her on a holiday if there was heavy bleeding after taking Misoprostol. However, such r igorous protocol was not followed by the practitioner working in the government hospital or in the rural area. They used u ltrasound sparingly since majority of their p atients belonged to lower income group and lowering the total cost of the procedure was important.

The rural practitioner used the drugs even in the second trimester and said that though she was aware of the recommended gestational age, the protocol she followed was based on her own field experience. As she articulated:

I give the tablets up to 12-13 weeks of pregnancy after confirming it by ultrasound. The books do talk about 49 days only, but I have excellent results up to 10 weeks. I use it even later for termination of foetal malformation cases. I give one Mifepristone orally and insert one Misoprostol vaginally in my clinic after checking with ultrasound and send the woman with two tablets of Misoprostol to take after 48 hours at 3 hours interval. I have used this protocol extensively and there is no need for dilation and evacuation.

Counselling and Management of Side Effects: Almost all the providers reported counselling their clients but felt that it tends to take more time compared to that for surgical abortion. The clients have to be told also about surgical abortion both as an option to medical abortion and as a possible back-up procedure for a failed medical abortion. They said that when the clients lacked knowledge about the recent developments, and had a tendency not to be actively involved, the counselling took time. But they also confessed that with experience, the time required decreased since they stressed orally on select points only. According to one practitioner:

I have some material given to me by the pharmaceutical company but I do not use it. Their material does not have Misoprostol mentioned and if my prescription is different from what the material says, I will get into legal trouble. Therefore, I believe in oral counselling rather than giving any material.

Only one out of 10 providers had written information, education and communication (IEC) material in local language for her clients and advised them and their families to go through the material before actually taking the drugs.

The providers insisted on consent of clients before prescribing the drugs because the purpose of medical abortion is also termination of pregnancy, and therefore, it falls within the legal purview of MTP Act. As one provider put it:

All the legal formalities apply to it [medical abortion] as much as they apply to surgical abortion. In fact, even the prescribing doctor and facility should withstand the same scrutiny as is the case with surgical abortion.

The providers informed clients about the possible side effects of the drugs. This was perceived as essential to mentally prepare the clients for the process where the timing of abortion varied between individuals and from the surgical abortion, where once the doctor carried out the p rocedure, the abortion is complete. One provider gave the following instructions to her clients:

(1) the time interval between taking of the drug and the actual onset of bleeding can vary between clients, (2) they should therefore be careful and stay home, (3) they should know the possible side effects, and (4) in case of any side effects persisting for unduly long period, they should return to the clinic.

Majority (eight out of 10) of the providers reported that less than one-fourth of the clients had any side effects. The provider from rural area gave estrogen tablets and even a cycle of oral contraceptive pills

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to her clients with heavy bleeding essentially to pacify them, In my rural practice, 15 to 20 per cent of clients come with heavy bleeding and abdominal pain. I check them and if no problem is detected, I just reassure them and give Oral G – a high estrogen tablet – if bleeding is heavy. Further, I give them a cycle of oral

pills after confirming that there are no residual products of conception in the uterus. Three of them said that they exercised

caution by prescribing pain killers, haemostatic agents and antibiotic tablets to their clients in anticipation of some pain or discomfort. As one stated:

I have never come across a single woman with side effects in my extensive practice. I ensure through prescription of pain killers, haemostatic agents and oral pills that none occur. I use these as preventive measures since I do not want to be bothered by women in the middle of the night. It is not convenient for them either.

Those who did not prescribe pain killers believed that pre-prescription counselling about likely excess bleeding or abdominal discomfort and further counselling after occurrence of side effects was enough to reassure her. According to providers counselling and proactive management are enough since most problems are neither serious nor long lasting.

Efficacy: All the providers rated the efficacy of the drug regimen, if properly adhered to, above 90 per cent. According to them only in rare case of incomplete abortion surgical intervention was required, which in turn was easy.

I have prescribed medical abortion to 500600 women till date. However, in only two women it failed where I had to resort to dilatation and evacuation (D & E). Doing D & E in these cases was very easy as the cervix was soft and dilated.

Except the providers from government hospital and from rural area, the remaining were of the opinion that the medical abortion drugs are effective in the early stages of pregnancy or up to seven weeks. The other two not only mentioned that the drugs can be used to terminate pregnancy of longer duration, but also stressed that since Misoprostol has been used for inducing labour in the second trimester even before the advent of medical abortion, it can be used to terminate pregnancy of more than 63 days of duration.

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Advantages of Medical Abortion: All providers felt that medical abortion is beneficial to both the providers and the clients. The technique is less risky, noninvasive, does not require anaesthesia, sterilised instruments or in-door stay for clients, all of which are required in surgical procedure. Therefore, staff, maintenance of facility and cost is minimal and beneficial for the providers. The regimen involves taking Misoprostol tablets at home thereby significantly reducing the demand on the provider’s clinic time.

Medical abortion is non-invasive and therefore requires less time. Same earning with less time investment for doctors!

Some providers claimed that multiple visits of the clients to the clinic ensured a stronger bond with them. At the same time, some providers felt that despite counselling some clients panic at the ill-timed bleeding and call at odd hours. This they perceived as a major disadvantage of the method.

According to the providers, from the perspective of women, the main advantage of medical abortion is that it is clientfriendly and the woman does not have to be admitted to the hospital. She can use the method without informing the family, if she needs to do so, particularly in case of pregnancy out of wedlock. Some providers questioned keeping family in the dark as an advantage. They believe that some family members should be informed in the interest of the women themselves. As d escribed by one provider:

Occurrence of side effects is always a possibility, which can complicate matters if the woman has taken the tablets without anyone’s knowledge in the family. Also, promoting secrecy from family can become counter-productive particularly if the woman deve lops serious side effects. I, therefore, insist that the person in the family who resists the woman using a particular method should meet me. I spend time explaining everything because I believe in transparent practice and feel that in the long run it is beneficial to the clients.

Securing Practice and Need for Training: The providers have claimed that since they cannot advertise their services through any media, they rely on satisfied clients to spread the word in the community that they provide medical abortion. Sometimes, women come on their own seeking medical abortion after learning about it from relatives or friends who might have used the method or known about it. Also, the providers themselves inform the clients who come for induced abortion about it being an alternative to surgical procedure. In fact, six out of 10 service providers believed that it is their responsibility to make the clients aware of various options, regardless of their own method preference.

Almost all providers pressed for repeated training in view of the rapid advances in medical technology. Many of them had obtained their medical education several years ago when medical abortion was not available. They also felt the need for being regularly informed and updated by reliable sources, about new research and products coming in the market and in other countries. When asked about the kind of training they would like to receive, seven out of 10 reported that direct experience of dealing with patients was the most e ffective method of learning. They would like scientific sources rather than medical r epresentatives to provide technical information about the dosage, efficacy, likely side effects and their management.

MTP Act and Medical Abortion: The providers were asked about applicability of MTP Act rules and conditions to medical abortion. Interestingly, seven out of 10 felt that since medical abortion resulted in termination of pregnancy, all the rules of MTP Act should apply to it as well. The method used for termination of pregnancy was not important; according to them. Since the MTP Act addressed the risk associated with expulsion of the product of conception, the act stipulations remained valid irrespective of method. The three who were a little uncertain felt that since medical abortion does not require any s urgical intervention or hospital stay, it should be covered by some modified rules. Overall, they believed that medical abortion did not involve the risk due to anaesthesia or surgical intervention, and therefore, was the safest abortion technique. The providers favoured promoting medical abortion as the safest abortion technique, through IEC targeted at both the clients and themselves.

All the providers explicitly mentioned that the medical abortion drugs should not be available with the chemists since they supply most of the drug to their clients over the counter. Nine of them also indicated that only a qualified gynaeco logist should provide medical abortion because they understand the pharmacology of the drug formulation, can anticipate and manage complications, if and when they arise. Also, they have the requisite skills and emergency back-up facilities in their clinics. Two even expressed a fear that easy availability of the drugs with the chemists or general practitioners would “increase immorality in the community. Illicit relationships and illegal pregnancies would be on the rise”.

3 Implications for Policy

In a country like India the consequences of unwanted pregnancy and efforts to terminate it in absence of knowledge of and means for safe abortion are grave. Medical abortion is emerging as an alternative to surgical procedure for terminating early pregnancy and offers a window of opportunity to expand women’s choices and a dvance their reproductive health.

The advantage of medical abortion is that it can increase the access to safe and effective abortion. There are however multiple challenges to wider reach of the method. Limited awareness of the stakeholders about the appropriate regimen, protocol and likely side effects, cost to the clients, resistance of providers of surgical abortion and the need for adequate b ack-up facilities are some of the critical challenges.

In our study gynaecologists confessed that to reduce the cost of recommended protocol they cut corners by doing away with some of the requirements specified (ultrasound examination) under the protocol, and thus to an extent compromised “safety” of clients. At the same time they were sceptical about the discussions in f avour of “de-medicalising” abortion and devolution of prescribing or dispensing power to the chemists, paramedics or even medical practitioners from other streams of medicine. The contention being that they understand the pharmacology, can anticipate and manage complications, and have the requisite skills and emergency back-up facilities in their clinics. This reservation of gynaecologists particularly about the role of chemists was re-inforced as they were found to be unaware about the protocol and side effects and directly sold the drug to clients without prescriptions in complete contravention of the legal stipulations. With this lack of accountability of chemists the onus of having a “safe” abortion was on the clients.

Nevertheless most of these challenges can be addressed to expand women’s choice. While media in the public health facilities can be used to create public awareness and understanding of the regimen, safety and efficacy, pool of trained personnel and thus access could be increased by training students of medicine and providing them with the right to prescribe the drugs. Those in favour of widespread use of medical abortion while countering the cost argument by alluding to the hidden costs of surgical abortion such as staff training, operating room time, and hospital stay, suggests that i nclusion of the drug in government programmes and thus offering it at a subsidised rate would be cost-effective. Opposition from service providers can be overcome through strong leadership from the medical establishment and by under taking empirical research programme. These proponents of medical abortion also feel that its increasing availability through public sources and largescale acceptance will create market conditions, which will encourage service providers to rethink about their resistance.

Chemists’ lack of knowledge about the medical abortion drugs and confusion with emergency contraception are causes for concern. The practice of many chemists making abortion drugs available to clients without the mandatory prescription would require stricter enforcement and vigilance. The pharma companies, on the other hand, need to play a responsible role while promoting their products and educate their medical representatives, particularly as they and the company web sites are the major sources of information for the providers. Even the likely opposition from women’s groups in India is not expected to be strong, since the method is woman controlled, designed for one-time use (not long acting), indicated for unwanted pregnancy, and difficult to impose on women against their will.

In light of the safety of medical methods of abortion and the likely increase in the demand for abortion services the grey area in promoting the method is the relevance of MTP Act in its existing form. The MTP Act was drafted when medical abortion was not available and the stringent stipulations made for surgical methods appear unwarranted for medical abortion which could be administered as an outpatient provision. The amended MTP Rules 2003 permit a registered medical practitioner with access to a surgical abortion facility to induce medical abortion using Mifepristone in his/her facility, but the Drug Controller of India has licensed Mifepristone for use only on the prescription of a gynaecologist [Hirvey 2003]. While re-visiting the MTP Act, and it appears inevitable, the need to regulate adherence to and penalise deviations from the stringent protocols cannot be stressed enough if women’s a ccess to “safe” abortion is to be ensured.

Notes

1 www.cipla.com / Our Products – Therapeutic Index – Abortificient – MTPILL.

2 Free-flowing discussion with the chemists while they attended their medical stores was not possible. Interviews were interrupted several times while clients came to buy drugs. Visiting them at home or elsewhere was not considered feasible or even desirable.

3 Except for one chemist, others were not even aware that tablets like Pill 72 and Ecce2 are emergency contraceptives to be taken within 48-72 hours of unprotected sexual intercourse.

References

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Abortion Assessment Project of India: Qualitative Studies, HealthWatch Trust, Jaipur, pp 22-41.

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Ganatra, B, V Manning, S P Pallipamulia (2005): ‘Availability of Medical Abortion Pills and the Role of Chemists: A Study from Bihar and Jharkhand, India’, Reproductive Health Matters, 13(26), pp 65-74.

Gupta, K (2004): ‘Early Pregnancy Termination with Reduced Doses of Mifepristone & Misoprostol: Results of a Single Large Trial Conduction in the Abortion-cum-Family Planning Department of an NGO Run Hospital in an Urban Setting’, Janani, www.janani.org/article 11.htm

Harvey, S M, C A Sherman, S T Bird and J Warren (2002):

Understanding Medical Abortion: Policy, Politics, and Women’s Health, Policy matters No 3, Research Programme on Women’s Health, Centre for the Study of Women in Society, University of Oregon.

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