**3. Drug regulators**

Most important organ of the governments that are directly responsible for implementation and execution of the Acts, Ordinances, Rules and Regulations related to clinical trials, manufacture, import, export, licensing, sale, distribution, storage and dispensing of drugs are the drug regulators though they are not at the forefront of pharmaceutical policy development in many countries like India where that task is accomplished directly by the ministries themselves. However for any comprehensive, practicable and robust policy development drug regulators are very important stakeholders for they are the ones who implement policies on ground and are in knowhow of the practical difficulties and hurdles in their implementation. Therefore without their consultation no policy document can be considered to be complete in all respects. That is the reason why in spite of being a government functionary drug regulators deserve a special mention as stakeholders in pharmaceutical policy development. On the basis of their past experience and practical knowledge they can be of immense help in giving significant inputs about the gaps, barriers, prospects and challenges towards adoption and implementation of new pharmaceutical policies like for instance universal health coverage policy, drug de-addiction policy, counter-spurious drug policy, effective pharmaceutical pricing policy, generic drug substitution policy, drug recall, disposal and withdrawal policy, drug procurement and medicines management policy etc.

Without the interest and active involvement of drug regulators quality assurance of medicines remains a far-fetched dream particularly in developing countries. This is illustrated by the very fact that India in spite of being a world leader in manufacture and supply of quality generic drugs to the extent that it covers 20–30 percent of the world market and is popularly known as the "pharmacy of developing world" yet a vast section of its own population to the extent of 50–65% was not having access to quality generics as per the World Medicines Situation Report [4]. However, the situation has drastically improved in recent years ever since Govt. of India implemented a whole lot of new Universal Health Coverage Schemes like Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), Pradhan Mantri Jan Aushadhi Yojana (PMJAY) and many others. Unlike previous schemes, AB-PMJAY covers larger population, provides more comprehensive benefit package and incorporates a wider network of hospitals for healthcare delivery. Thus in spite of several universal health coverage policies like *Jan Aushadhi* (people's medicine) scheme, *Rashtiya Swasth Bhima Yojna* (National Health Insurance Scheme) and recently launched *Ayushman Bharat* (Long live India) having been launched in the past by the successive governments of India, quality and effectiveness of generic drugs supplied free of cost at government health facilities continued to remain doubtful and unreliable for a long time thereby affecting the overall success of these government schemes and primarily it was the failure of drug regulators in ensuring fool-proof quality assurance system. Paucity of government drug testing facilities, inadequacy of the drug inspectorate staff, insufficiency of the funds, manpower and equipments at govt. drug testing laboratories, less testing capacity and high testing load resulting into high lead time of testing, unscientific and unsystematic drug coding, sample handling and testing

procedures were some of the issues confronted in the quality assurance system of developing countries where drug regulators have a major role to play as important stakeholders in the pharmaceutical policy development and implementation.
