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Analysis On Drug Control And Regulation Policies

The Narcotic Drugs and Psychotropic Substances Act, or NDPS Act, was enacted to control addictive drugs and prohibit their possession, dispersion, sale, import, and trade in India. Psychotropic agents have the potential to change an individual's consciousness, while narcotic drugs relieve anxiety. The Indian Parliament passed the NDPS Act on November 14, 1985. Nonetheless, these types of drugs are important in the practice of medicine. Consequently, the Act contains provisions for the cultivation of cannabis, poppy, and coca seeds and the production of certain psychotropic medicines used for medical purposes.

The Act's primary objective is to regulate the manufacturing, ownership, selling, and transportation of narcotics and psychotropic drugs. The Act forbids the selling of nearly 200 psychotropic medications, resulting in these drugs being inaccessible over the counter to the general public. These medications are only available for use with a prescription. Violations of this law can result in a sentence of incarceration or a fine, or both, depending on the offense's severity, which is determined by the severity of the situation at hand. If the drugs are being used for personal benefit, the penalty can be minimized.

Furthermore, the legislation has been revised several times since its inception. Medicines or drugs have several properties that are unique and differentiate them from other consumer products. In most cases, patients do not have the expertise to conduct an independent assessment of the safety, quality, and effectiveness of drugs.

Given the asymmetry of information. The need for regulatory oversight is widely recognized by all public health stakeholders among manufacturers, physicians who prescribe drugs, and patients who ultimately consume them. The quality and effectiveness of medicines also help build trust in health systems, health professionals, manufacturers and distributors of medicines in the country.

Therefore, the goal of all regulatory systems for medicines is to ensure that they are safe, high quality and effective drugs reach patients. The mechanisms for achieving these objectives rightly differ, however, as the nature and extent of the regulatory space that frames the functioning of these systems vary from country to country, creating significant challenges for the principles of design and structure.

Drug regulation is a public policy response to public health demands and the changing needs of the pharmaceutical industry (Ratanawijitrasin and Wondemagegnehu, 2002). Therefore, the aim of regulatory scrutiny is to strike a balance between protecting and promoting public health and facilitating compliance, and the measures needed to tackle non-compliance should be designed in such a way that there is room for regulation and especially the actors who operate in this space. This is the basic premise of the conceptual approach of Smart or Responsive Regulation.

Regulation, but also take into account the rank and intrinsic characteristics of each of the regulators (Ayers and Braithwaite, 1992). In the context of India, the drug regulatory architecture is designed as a classic command and control system where the regulator prescribes standards, distributes licenses, and then conducts inspections to verify compliance.

However, this system also requires a significant amount of resources, from setting standards to keeping records, conducting inspections, collecting and analyzing samples, etc. Drug Discovery, India can currently be characterized as a country that is on concentrates on the manufacture and export of generic drugs for Family Health and Welfare (MOHFW) this year.

Thus, since the Mashelkar Committee Report (2003) was published, the situation has remained practically unchanged for over a decade (ideally the recommendations should now have been implemented and even further improved) Medicines Standards Control Organization (CDSCO) (2012) (hereinafter the 59th report of the Parliamentary Committee) and the Ranjit Roy Chaudhary Committee Report (2013) and more recently the Department and Cosmetics (amendment) report of the Standing Committee on Health and Wellbeing in of the family (amendment), 2015 (hereinafter DCA Bill, 2015).

Being a country with significant volumes of licit and illicit drug cultivation, a transit route as well as a consumer market, India's drug policy dilemmas span 'demand' and 'supply' control. Its large chemical and pharmaceutical industry draws the country into deliberations on the illicit manufacture of drugs and precursor control as well as the nonmedical use of prescription drugs.

Some parts of the country report alarmingly high rates of drug dependence, HIV and viral hepatitis amongst people who inject drugs, making health and harm reduction important policy considerations. While India's harsh drug control laws (in particular the criminalization of drug use and the imposition of the death penalty for certain drug offences) conform strictly with prohibition, its regulated opium cultivation industry provides insights for countries that are experimenting with alternatives to prohibition.

What Is National Drug Policy?

A national drug policy is a commitment to a goal and a guide to action. It expresses and prioritizes the medium and long-term objectives set by the government for the pharmaceutical sector and identifies the main strategies to achieve them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated. It covers both the public and private sectors and involves all the major players in the pharmaceutical sector.

A national drug policy, presented and printed as an official government statement, is important because it serves as a formal record of aspirations, goals, decisions and commitments. Without such a formal policy document, there may not be a general overview of what is needed; therefore, some government actions may conflict with others because the various objectives and responsibilities are not clearly defined and understood.

The policy document should be developed through a systematic consultation process with all interested parties. In this process, goals must be defined, priorities must be established, strategies developed and commitment built.

Why Is A National Drug Policy Needed?

To present a formal record of the government's values, aspirations, goals, decisions and commitments in the medium and long term:
  • Define national goals and objectives for the pharmaceutical sector and establish priorities;
  • Identify the strategies necessary to achieve these objectives and identify the different actors responsible for the implementation of the main components of the policy.
  • Create a forum for national discussions on these issues.
The national consultations and discussions leading to the production of the drug policy document are very important, as they create a mechanism to bring all parties together and achieve a sense of collective ownership of the final policy. This is crucial given the national effort that will subsequently be required to implement the policy. The political process is just as important as the political document.

Objectives Of A National Drug Policy:

In the broadest experience a country wide drug coverage must sell fairness and sustainability of the pharmaceutical sector.

The popular targets of a country wide drug coverage are to ensure:
  • Access: equitable availability and affordability of critical drug treatments, such as conventional medicine;
  • Quality: the quality, protection and efficacy of all drug treatments;
  • Rational use: the promoting of therapeutically sound and cost-powerful use of drug treatments by fitness experts and consumers.

The extra unique dreams and targets of a country wide coverage will depend on the U.S. situation, the country wide fitness coverage and political priorities set by the authorities. In addition to fitness-associated dreams there can be others, inclusive of monetary dreams.

For example, a further goal can be to increase country wide pharmaceutical manufacturing capacity. It is important that each one the drug coverage targets are explicit, in order that the jobs of the general public and private sectors and of the numerous ministries (fitness, finance, alternate and industry) and authority's bodies (inclusive of the drug regulatory authority) may be specified.

In India, The Approval, Production, And Marketing Quality Drugs At Reasonable Prices Is Ensured By The Following Regulatory Bodies:

The Central Drug Standards and Control Organization (CDSCO)
  • CDSCO functions under the Ministry of Health and Family Welfare
  • Prescribes standards and measures for ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics and devices in the country;
  • Regulates the market authorization of new drugs and clinical trials standards;
  • Supervises drug imports and approves licenses to manufacture the above-mentioned products;

The National Pharmaceutical Pricing Authority (NPPA), 1997
  • The NPPA functions under the Department of Chemicals and Petrochemicals.
  • fixes or revises the prices of decontrolled bulk drugs and formulations periodically
  • updates the list under price control through inclusion and exclusion of drugs in line with prescribed guidelines periodically;
  • maintains data on production, exports and imports and market share of pharmaceutical firms;
  • Monitors the shortage of medicines in addition to providing inputs to Parliament in issues pertaining to drug pricing.

The Ministry of Health and Family Welfare examines pharmaceutical issues within the larger context of public health while the focus of the Ministry of Chemicals and Fertilizers is on industrial policy. In July 2008,the cabinet Secretariat, created a new department under Ministry of Chemicals and Fertilizers - the Department of Pharmaceuticals, with the objective of giving greater focus and thrust on the development of Pharmaceutical Sector in India and to regulate various complex issues related to pricing and availability of affordable medicines, research & development, protection of intellectual property rights and international commitments related to pharmaceutical sector which require integration of work with other ministries.

All The Drugs And Pharmaceuticals, Unless Specifically Allotted To Any Other Department, Would Come Under The Purview Of The Department Of Pharmaceuticals. The Main Functions And Responsibilities Of The Department Are As Follows:

  • All matters relating to NPPA including its functions of price control and monitoring.
  • Responsible for the drugs and pharmaceuticals, excluding those specifically allotted to other departments, and for the development of infrastructure, manpower and skills for the pharmaceutical sector
  • Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research.
  • Entrusted with the task of maintaining inter-sectoral coordination between organizations and institutes, both under Central and State Governments, related to areas concerning the subject.
  • To deal with all matters relating to planning, development, and control of, and assistance to, all industries in the pharmaceutical segment.
  • Promotion of Public Private Partnership (PPP) in pharmaceutical related areas.

Other minister's role
  • The Ministry of Environment and Forests, Ministry of Finance, Ministry of Commerce and Industry and the Ministry of Science and Technology also have a part to play in the regulation process. The process for drug approval requires the coordination of different departments, in addition to the DCGI depending on whether the application in question is a biological drug or one based on recombinant DNA technology.
  • The Department of Industrial Policy and Promotion and Directorate General of Foreign Trade, both under the aegis of Ministry of Commerce and Industry and the Ministry of Chemicals and Fertilizers, look into matters related to industrial policy such as the regulation of patents, drug exports, and government support to the industry.
  • Licensing, quality control issues, market authorization is regulated by the Central Drug Controller, Ministry of Health and Family Welfare, Department of Biotechnology, Ministry of Science and Technology and Department of Environment, Ministry of Environment and Forests.
State drug controllers have the authority to issue licenses for the manufacture of approved drugs and monitor quality control, along with the Central Drug Standards Control Organization.

Policies And Guidelines Are Evolving In The Allied Fields Of Medical Devices And Biotechnology In India

Medical devices

  • The JJ Hospital controversy, involving the use of unapproved and untested stents on 60 patients and the subsequent recommendations made by the Mashelkar Committee in 2004 resulted in the Department of Medical Education and Research (DMER) banning the use of unapproved stents and stressing on regulatory approvals from the country of manufacture or US-FDA approval for medical devices.
  • Following on from the incident, in June 2007, the DCGI introduced a new set of guidelines for the import and manufacture of medical devices in the country.
  • The Mashelkar Committee subsequently recommended the creation of a specific medical devices division within the CDSCO in order to address the management, approval, certification and quality assurance of all medical devices.
  • This essentially consisted in alteration of the status of sterile medical devices, intended for internal or external use to medical drugs and creation of suitable provisions and amendments to the Drugs and Cosmetics Act of 1940.
  • The Drugs Consultative Committee approved these recommendations in 2005, ensuring that in future all devices would be licensed for manufacture, distributed and sold by the CDSCO, with special evaluation committees in order to ensure that the concerned manufacturing units complied with the requisite GMP requirements.

Biotechnology and related products

  • The Department of Biotechnology [DBT] constituted under the Ministry of Science and Technology is the parent body for policy, promotion of R&D, international cooperation and manufacturing activities.
  • Together with DBT, Genetic Engineering and Approval Committee [GEAC] constituted under Ministry of Environment and Forests [MoEF] is the key regulatory body in Biotechnology in India. Several committees have also been constituted under the said ministries to regulate the activities involving handling, manufacture, storage, testing, and release of genetic modified materials in India.
  • The Institutional Bio Safety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC) to monitor rDNA research, product development and commercialization. The ISBC functions as the nodal point for interaction within the institution for the implementation of the rDNA Biosafety guidelines. The RCGM essentially monitors the safety related aspects of activities involving genetically engineering organisms or hazardous microorganisms.
  • The GEAC undertakes the responsibility of approval of activities involving large-scale use of genetically modified/hazardous microorganisms and products thereof in research and industrial production and their safety in terms of environmental protection. In addition, the DCGI and state drug controllers as per the Drugs and Cosmetics Act 1945 and its subsequent amendments regulate biologicals.

Policies relating to clinical trials

  • Till about a decade ago, there was little or no visibility with regard to the conduct of quality clinical trials in India-compliant to regulatory standards and ethics. The Central Drugs Standards Control Organization (CDSCO) has played a critical role in bringing about a positive change in the clinical trials landscape for India. The progression towards Good Clinical Practice (GCP) has largely been a gradual and slow process.
  • In 1988 local clinical trials for new drug introductions were first made mandatory in India. Along with the changeover to product patents in January 2005, India also amended the schedule Y of the ''Drugs and Cosmetics Rules'' to allow drug trials without a phase lag in the country, that is, Phase II and Phase III trials were permitted only after these had been carried out elsewhere in the world.
  • The new rule permitted conducting the concurrent trials of the same phase in India. Also Drugs Technical Advisory Board (DTAB) made GLP practices mandatory for all laboratories and in-house units of pharmaceutical firms and Contract Research Organizations (CROs).
  • Reports of incidents of ethical violations related to informed consent and conduct of trials by multinational and domestic organizations were known prior to the year 2000. In 2000, the regulators - the Central Ethics Committee on Human Research (CECHR) and Indian Council of Medical Research (ICMR) took proactive initiative to conceptualize and issue the Ethical Guidelines for Biomedical Research on Human Subjects.
  • The Good Clinical Practice (GCP) guidelines were developed in line with the latest WHO and ICH guidelines in 2001 by Central Expert Committee -set up for the purpose by Central Drugs Standards Control Organization (CDSCO)
  • Subsequently in 2005, the requirements of data submission on animal testing for permission to undertake Phase I, Phase II and Phase III clinical trials were laid down in the revised Schedule Y of the Drugs and Cosmetics rules.
  • Clear responsibilities for investigators; and sponsors were specified and notifying changes in the protocol were made mandatory. Expert clinicians & scientists from the industry assist the evaluation of the relevant data submitted to the Drugs Control General of India (DCGI).
  • Similarly, for registration and approval of new drugs, which have already been registered and used in the country of origin, The DCGI mandates Phase II trials in about 100 prior to allowing such products to be marketed in India. Normally, new drug approval is usually granted for a period of about two years. The trials are conducted only after clearances are obtained from the Institutional Ethics Committees. Consent of patients for participation in such trials is an integral part of the regulatory framework.
  • However, there remains a need for the establishment of pharmacovigilance centers at national, zonal and regional levels to monitor adverse drug reactions to be met.
Scientific evidence-based treatment needs to be made available for people with Substance use disorders - at an adequate scale.

Evidence-based substance use prevention programs are needed to protect the young people: Prevention programs must address the risk and protective factors aimed at not just preventing substance use but ensuring that young people grow and stay healthy into adulthood, enabling them to realize their potential and become productive members of their community and society.

A conducive legal and policy environment is needed to help control drug problems: It is important that laws and policies are aimed at providing health and welfare services to people affected by substance use rather than subjecting them to the criminal justice system. There needs to be efficient coordination between the drug supply control sector as well as the entities involved in drug demand reduction and harm reduction.

The approach of generating and utilizing scientific evidence must continue: Every piece of the data would serve to incrementally inform evidence-based policies and programs to protect and promote the health and welfare of Indian society.


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