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| Dr Chintamoni Ghosh |
Medicines (i.e. drugs, diagnostics and vaccines) and healthcare services are essential goods and their universal accessibility is necessary to promote equitable, as well as efficient economic growth. According to a recent report on ‘Access to Medicines’, one-third of the world’s population does not have access to basic and essential drugs and this figure rises to one-half if the poorest parts of Africa and Asia are considered. Keeping in mind that medicines are important in curing and preventing diseases, the ultimate goal of ‘Health for All’ cannot be achieved if people do not have adequate access to medicines. Thus here the Government’s role in creating access to medicines is crucial, particularly in developing countries like India, where a large part of the population still lives below the poverty line.
India belongs to the group which is not only self-sufficient in production of medicines, but also exports substantial amount to developed and other developing countries. However, the healthcare system in this country is such that it supports availability of drugs in private retail market only, while affordability is seriously low.
Under the current changing environment, the Indian pharma industry is mounting up the value chain. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards basic, research-driven, export-oriented, global presence providing a wide range of value added quality products and services, innovation, product lifecycle management and enlarging its market reach.
In the immediate pre-independence era (1940), the pharma industries of Bengal shared more than 80 per cent of the national drugs production that has gradually been reduced to less than eight per cent. The Government of West Bengal has its own drugs policy since 2004. The drug policy document not only mentions the policy statement, but also outlines the strategies and mechanism towards implementations of policy mandates and commitments.
The main aims and objectives of ‘State Drug Policy — West Bengal 2004’ are:
- To maximise essential medicines to people
- To promote rational use of medicines
- To facilitate rational pharma management in government health facilities
- To foster growth and sustainability of state level pharma industries
- To ensure compliance of drugs legislation/ regulations and quality assurance (Hospital Efficiency in West Bengal, 2012)
Agriculture is the backbone of West Bengal’s state economy. Industrial and service sectors also contribute in the development of the state’s economy. The pharma industry, mainly formulation units, require less land compared to other heavy industries and return on investment is fast.
The prime objective of a regulatory agency is the availability of safe, effective and quality medicines at affordable price to the nation. Enforcement of the law depends on the degree of offence, which may vary from country to country but presence of Not of Standard Quality (NSQ) drugs and high price are mainly due to lack of proper enforcement of the regulatory law of the country. So the regulation is neither efficient nor effective if it is not implemented properly.
Apart from conducting regular checking of unregistered pharma companies and spurious drugs in the market, the state drugs control authority provides information about banned drugs, price notifications, attends to complaints related to the service of chemists and druggists, and addresses the adverse reaction caused by any drugs in the state. In addition to these functions, the drugs control administration is entitled to grant a renewal of drugs license for selling premises and manufacturing facility. A total of 175 blood banks, including non-government sector and 23 blood storage units are operating in West Bengal. They are regulated by this Directorate jointly with the Central Government. The authority also has joint responsibilities along with the central regulatory agency for approval of setting up of new Approved Drugs Testing Laboratory, Large Volume Parenterals (LVP), Medical Device and issue of WHO GMP certificates. Free sell certificate for export purpose, market standing certificate and production capacity certificate for participation of tender are also issued by this directorate.
Apart from this, the state drugs control authority ensures the implementation of Drugs Price Control Order, 1995, The Drugs and Magic Remedies (Objectionable Advertisement) Act 1954, The Narcotic and Psychotropic Substance Act 1986 and West Bengal Narcotic and Psychotropic Substance Act for the availability of morphine related products in the Palliative care unit, mainly for the cancer patients to protect and maintain safe and secure public health.
The state drugs control is always concerned about the spurious and counterfeit drugs in the market. It has become a challenge to the state authority and will form a special task force for continuous vigilance to susceptive points.
The state government is committed to the public in providing good healthcare services. One of the rules considered will be Public Private Partnership (PPP) initiative. The state government is setting up a fair price shop, namely ‘Salpa Mulyer Ousadher Dokan’ in different medical colleges and hospital, which will be entered into the block level. The state drugs control authority is actively involved in implementation of this project for availability of essential medicine at competitive prices.
Taking forward its initiatives, a special team of this directorate visited different chain pharmacies and pharmacy, situated in different corporate hospitals with various facilities in Kolkata and actions on the violations have been initiated with provision of the law.
West Bengal is a potential market with a large target population in the Eastern and North Eastern states. It boasts of successful implementation of land reforms, with a developed rural economy resulting in an increase of purchasing power. Prime medical facility exists in Kolkata, Durgapur and Siliguri for patients from neighbouring countries, especially Bangladesh, Nepal and Bhutan. The pharmacy education in West Bengal was started 60 years back with the opening of Diploma Course in Jalpaiguri Pharmacy College. The Department of Pharmaceutical Technology is celebrating its 50 years of pharmacy course this year. Now the state has nine pharmacy colleges and also NIPER Campus in Kolkata. Even, educational institutes are showing interest to take part in the growth of pharma industries in the state.
The Directorate of Drugs Control of the state too has extended a helping hand to pharma producers in meeting the global standards in stages. Since all surviving industries in West Bengal are GMP compliant, requirements of advanced tools and technology, validated and aseptic processing will no more be a problem. A strong motivation within the pharma industry is now required to regain its lost pride and position.
(The author is Director of Drugs Control, Government of West Bengal)
