Professor, MVN University Palwal, Haryana |
Former State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India |
Email: narendervivek16@gmail.com
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Last Updated on October 20, 2024 by The Health Master
Contraceptive
Contraceptive: Family planning is crucial for the achievement of sustainable development goals.
Limited access to family planning commodities poses significant risks of unintended pregnancies, maternal health and infant mortality, and hinders progress towards achieving national and global development goals.
Over the years, India has made significant leap in access to family planning.
Access to family planning has a multifaceted impact.
Evidence suggests that the possible control over family size and birth interval through use of family planning may also be critical pathways to increasing women’s empowerment eventually leading to gender parity in the workforce[1].
The translation of current basket of choices to methods are dominated by female sterilization
India’s family planning landscape has long been dominated by female sterilization which accounts for 67 percent of the modern contraceptive use.
Despite ongoing efforts to diversify family planning methods, as per latest round of NFHS-5, under 5% women rely on oral contraceptives, that is mostly supplied by the public distribution system through the ASHA workers.
This disparity is particularly concerning given that younger women, especially those aged 18-29, would benefit from newer OCP formulations that are better suited to their health needs.
Regulatory Barriers to Contraceptive Access
The regulatory issues stem from the fact that over the counter policy in India is still under consideration and earlier two committees of Drug Consultative Committee (DCC) have submitted their reports and the status of over the counter for contraceptives is achieved in implied manner by providing certain exemptions for 5 chemical compositions of oral contraceptives under the schedule K of the Drug and Cosmetic Act.
The exemption was implied to be of that of sale license.
Since the individual components of these contraceptives were never deleted from the schedule H it attracts labelling requirement of the Rule 96 and clause (b) of sub-rule (1) of the Rule 97 of Drug rules, i.e. not to be sold without prescription.
Since the sale license is exempted, these rules are contradictory. This non deletion of these oral contraceptives from Schedule H, exemption under Schedule K becomes redundant.
No one can imagine a Kirana Shop owner reading prescription of Registered Medical Practitioners and dispensing / selling these oral contraceptives.
Due to this confusion, these above discussions feature many times in the Drug and Technical advisory board (DTAB) meetings, including recently in the 91th DTAB meeting in September2024.
However, most discussion on these happen in context of 2 out of the 5 chemical compositions added in the schedule K, incidentally only those that feature in public distribution system, and hence labelling issues effects the private sector more.
This creates a significant barrier to access, particularly in rural areas where women might not have easy access to a registered medical doctor.
Advertising Restrictions under the DMRA
Another major barrier is the Drug and Magic Remedies Act 1954 (DMRA), which prohibits the advertising of drugs related to contraception, miscarriage, and menstrual disorders.
Although provisions exist for securing permission to advertise contraceptives, the process is neither clear nor streamlined for manufacturers, leading to minimal public awareness efforts.
In an era when consumer-driven awareness is key to healthcare access, the restrictions on advertising exacerbate the lack of information about contraceptive options.
Under Consumer Protection Act informed consumer is the basis making choice by the consumer.
This is particularly damaging to the uptake of OCPs, as women are less likely to choose an option they know little about.
The current landscape for family planning in India ends up in methods like female sterilization.
The lack of effective promotion for OCPs limits women’s ability to make informed decisions about newer, safer, and more suitable contraceptive options to space their childbirth.
The Need for Policy Reforms
On long term, to improve access to contraceptives, it is imperative that India implements strategic policy reforms that address these regulatory barriers.
A clear Over the Counter (OTC) policy for contraceptives is essential, especially for those that are safe and globally available without a prescription.
Notably, the FDA in the United States recently approved a low-dosage PoP (Opill) for OTC use, highlighting the global recognition of the safety and efficacy of these products.
Introducing such a policy would simplify the distribution of PoPs and CoCs, removing the prescription requirement for certain contraceptives while promoting greater consumer awareness through advertising.
Furthermore, revising the DMRA to allow for more liberal advertising of contraceptives is vital.
A balanced approach to promotional activities, one that educates women on proper contraceptive use without crossing into obscenity, is both possible and necessary.
Without changes to advertising guidelines, women will continue to lack the awareness needed to make empowered choices about their reproductive health.
Toward a Supportive Ecosystem for Contraceptive Access
Creating a supportive ecosystem for contraceptives in India will require a multi-faceted approach that involves regulatory clarification, policy reforms, and a concerted effort to raise awareness.
The Ministry of Health and Family Welfare (MoHFW) should issue clarifications on the current application of Schedule K, explicitly stating that the contraceptives listed under this schedule do not require a prescription.
On a long term basis a separate over the counter policy in the drug and cosmetic law should include contraceptives to improve choices for women.
Conclusion
India has always been a pioneer when it came to family planning policies. MoHFW has made many strides to bring the total fertility rate to near replacement level.
While there have been advancements, particularly in the availability of low-cost contraceptives through public channels, the country still lags in providing a full range of options, especially through private channels.
Policy reforms, including the introduction of an OTC pathway and relaxed advertising regulations, are critical to overcoming these barriers.
These changes will not only empower women to take control of their reproductive health but also contribute to India’s broader health and development goals under the National Family Planning Mission 2030.
India has a strong pharmaceutical manufacturing base, and there is no reason why it should not lead the way in providing affordable, accessible contraceptives to its population.
[1] Dhak, B., Saggurti, N., & Ram, F. (2019). Contraceptive use and its effect on Indian women’s empowerment: evidence from the National Family Health Survey-4. Journal of Biosocial Science, 1–11. doi:10.1017/s0021932019000609
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