The Central Drugs Standard Control Organization (CDSCO), operating under the Director General of Health Services, MoHFW, serves as the primary national regulatory authority (NRA) in India. India is an active member of the Southeast Asia Regulatory Network, which seeks to increase access to high-quality medicines including MA products in the WHO member states in the region [18, 19].

In India, new medicines are initially registered, reviewed and then centrally approved by the drug controller under CDSCO with a restricted license issued for the period of three years [20, 21]. If the product meets quality and compliance standards consistently over three years, the restricted license transitions to a general license, and manufacturers can seek registration of their products with the state-level Food and Drug Control Administrations (FDCA). These FDCAs are then responsible for regulation and manufacturing of MA medicines in their state. Once a product is approved by either CDSCO or state-level FDCA, it is eligible for marketing and distribution throughout the country. This also applies to MA medicines [10].

CDSCO manages an e-portal named SUGAM [21], which offers the up-to-date data on approvals, licenses, and details of all medicines manufacturing facilities including information on formulations and prescribed use for Schedule H drugs. The current licensed drug list of CDSCO includes misoprostol (Sr. No. 869) which is approved for “cervical ripening, prevention of postpartum hemorrhage and first trimester abortion along with mifepristone”. The list also includes mifepristone (Sr. No. 1039) approved for use “by Gynecologist only—for medical termination of intrauterine pregnancy through 49 days of inception” and a combi-pack of mifepristone + misoprostol (Sr. No. 1782) “for the medical termination of intrauterine pregnancy of up to 63 days gestation based on the first day of the last menstrual period” [21].

We identified 42 combi-pack products by 35 manufacturers available in India discerned through manufacturers’ and social marketers’ websites and online pharmacies (Table 1). These products are approved by a state-level FDCAs based upon the initial combi-pack approved by CDSCO in 2008 (Sr. No. 1782), however, their exact registration status within the country could not be verified. These 35 combi-packs manufacturers are distributed nationwide, with some operating in multiple states. Two misoprostol products manufactured in India are WHO PQ-listed and one combi-pack is SRA-approved; all three products are intended for export and manufactured in dedicated facilities (Table 1). There is an opportunity for the local manufacturers of MA medicines towards achieving WHO-PQ, which can elevate their global contribution, enhancing access to quality MA medicines.

State FDCAs in India oversee regular inspections of manufacturing sites for compliance with current good manufacturing practice (cGMP) and for monitoring adverse reactions. In India, there are two basic approvals for manufacturing facilities. One is cGMP determined by state FDCA inspections and based on the inspection risk-assessment. The other is cGMP determined by joint inspection by CDSCO Zonal Officers and inspectors using a quality risk approach and a checklist relying on the WHO cGMP scheme for pharmaceutical products, and on national Certificates of Pharmaceutical Product, also based on WHO guidelines. Both types of inspections happen approximately every three years. For hormonal products like, misoprostol, to align with WHO cGMP standards, manufacturers must maintain a dedicated hormonal facility for production.

In public sector procurement systems, quality assurance, three random samples from manufacturing sites or pharmacy registers are selected at the central warehouse. These are then dispatched to the Head Office of Drug Control and then subsequently sent to three different labs for analysis. Should medicines fail to meet assay or pharmacopeia standards, district warehouses receive directives to freeze the stock until the Quality Control Department issues further directions on next steps [22].

Abortion care is integral to India’s Reproductive, Maternal, Newborn, Child and Adolescent Health (RMNCAH) strategy and is incorporated into national service delivery guidelines and the National Health Mission (NMH) Program Implementation Plans [10]. Although robust national policies exist and guidelines on provider eligibility, capacity building and financial support for MA medicine procurement are already in place [1, 11, 12] state-level variations persist.

The national essential medicines list (EML) guides public sector procurement, but states have autonomy to formulate their essential medicine lists based on the specific requirements. This assessment identified that while national policy and inclusion of mifepristone and misoprostol exists, translation into state EMLs is inconsistent. For example, in Tamil Nadu, the 2019–2020 EML includes misoprostol (200 mcg tablet) and mifepristone on a separate “Specialty Drug List” for public tender – a temporary designation for newly added medicines. In Rajasthan, the 2020 EML includes mifepristone tablets for primary health centers and misoprostol tablets for sub-centers and above. However, the MTP combi-pack, not in the EML, is on an approved rate list and is procured by the Government of Rajasthan [23].

Public sector procurement of MA medicines is devolved to the state level; there is no centralized procurement system at the national level. State governments have established corporations to procure essential medicines through bulk purchasing utilizing their NHM funds.

These funds are allocated based on Program Implementation Plans submitted by the states. During the fiscal year 2019–2020 and 2020–2021 under the budget head of ‘Drugs for Safe Abortion’ varies and is contingent on state needs and the availability of existing stock; budget needs and allocations are generally based on previous trends. Financing (including procurement) of MA medicines varies significantly across states despite national level efforts to allocate funds to purchase MA medicines.

The variation in requirement also poses challenge for procurement. States with small quantity tender volumes may not be attractive to the large manufacturers for competing for tenders. A review of a sample of public tenders at state level reveals that there is variation in combi-pack tender volumes across states. For example, in Rajasthan and Tamil Nadu, the tender volume is on average 17,000 and 15,000 combi-packs, respectively, compared to larger public-sector tenders in states like Madhya Pradesh (80,000) and Karnataka (40,000).

Besides small tender volumes, there are also other factors which dissuade commercial manufacturers from competing for public tenders, such as onerous paperwork, payment delays, and preference for in-state suppliers to promote local businesses. The non-governmental sector has an important role in procurement and distribution of MA medicines through public–private partnerships.

MA medicines are also available for purchase upon prescription through retail pharmacies. There is wide variability in the availability of MA medicines in pharmacies across states. A large-scale medicine survey of essential medicines conducted by the MoHFW in 2014–16 found that misoprostol has limited availability in retail outlets [24]. Data from NGO pharmacy surveys indicate that chemists cite strict monitoring and reporting by state-level FDCAs as reasons for ceasing to stock and dispense MA medicines in pharmacies [23,24,25]. Key informant interviews in both states corroborate the finding that documentation requirements for pharmacists (copies of prescriptions on file, client signatures) and the risk of loss of license, create barriers to pharmacists’ willingness to stock MA medicine. Pharmacies affiliated with hospitals with obstetricians and gynecologists are most likely to stock MA medicines.

The national health survey clearly shows that the majority of abortions are performed in the private health sector (53%), and only 20% in the public health sector [4]. There is a robust private sector market for MA medicines in India with not only commercial distributors but also social marketing organizations distributing and selling MA medicines through a variety of private sector providers, outlets, clinics, and pharmacies [25].

The MTP Act defines who can provide abortion in India [1, 11]. Medical doctors are permitted to perform MTP up to 20 weeks’ gestation if they have a post-graduate degree or diploma in obstetrics and gynecology, have completed six months of residency in obstetrics and gynecology or have at least one-year experience in the practice of obstetrics and gynecology. Physicians with a Bachelor of Medicine, Bachelor of Surgery (MBBS) are only permitted to provide first trimester (up to 12 weeks’ gestation) MTP/CAC services after completing training at a government approved training center or hospital and becoming a certified provider [12].

Funding for the training of these providers is allocated under the NHM Program Implementation Plan which primarily targets training master trainers and Medical Officers. However, CAC training is inconsistent, highlighting the need for optimized fund utilization. Interviews with providers highlighted the need for innovative approaches to teaching and learning without diverting providers from service delivery.

The study reveals a significant gap in providers’ awareness of the updated national abortion guideline, and the abortion law in India [11, 26]. Although the combi-pack is approved for use up to nine weeks (63 days) of gestation, many providers limit its use to seven weeks (49 days) of gestation, per the MTP Act. Additionally, invasive practices, like dilatation and curettage, are still commonly practiced [4, 26,27,28,29]. Key informant interviews showed that knowledge of the WHO Abortion Care guideline is inconsistent. There is lack of alignment between WHO recommendations for use of MA medicines, which is up to 12–13 weeks of gestation [2, 3], the combi-pack regulatory approval (9 weeks) and the MTP Act. This creates challenges in evidence-based decision-making in abortion care services, particularly in private sector, which often sees minimal regulatory supervision.

This assessment, primarily based on literature review, indicates a significant knowledge gap regarding abortion legality and availability of safe services, particularly among young and unmarried [4]. The stigma surrounding abortion is pronounced, especially in rural areas, and the emphasis on sex-selective abortion has fostered a widespread belief that all abortions are illegal [4, 28, 29]. Despite free services in the public sector, many abortions take place in private sector at considerable out-of-pocket costs (retail cost ranges from 335–600 INR, equivalent to USD$4-$7.25), due to unawareness about free services in public sector [30, 31]. Woman’s negative perceptions of the legality, quality, privacy and confidentiality, and hostile public facility environment deter women from accessing public sector services, often resulting in unsafe abortion practices [4, 30,31,32].

Community awareness activities about safe abortion services is not uniformly prioritized and varies across the state-level. The Reproductive, Maternal, Newborn, Child and Adolescent Health program calls for, “Routine orientation and training of Accredited Social Health Activists to equip them with skills to create awareness about abortion issues in the community and facilitation of women's access to services”, yet dedicated funding for this initiative is often absent.