India will soon have an exhaustive database on all drug formulations sold in the country. This will come in the form of a “National Drugs Database”, envisioned to be a comprehensive repository of drug formulations manufactured and marketed within India. The move, announced by the Central Drugs Standard Control Organization (CDSCO), aims to strengthen the monitoring mechanism and plug loopholes in the regulatory system. The government believes this will ultimately empower and benefit consumers.
To prepare this database, the Ministry of Health and Family Welfare has decided to constitute a committee. The committee will give recommendations and prepare a comprehensive database of drug formulations manufactured and marketed in the country, providing detailed information on a drug, its dosage form, strength, and details of the manufacturer, marketer, or importer of the drug. The committee will also examine the existing database available with various authorities including states and union territories’ drug control departments.
The announcement comes close on the heels of the unfortunate death of 66 children in Gambia caused by the consumption of cough syrups made from substandard toxic ingredients by a little known domestic firm. India’s drug industry is often faced with challenges around a lack of quality control and data monitoring, inadequate testing, and absence of oversight of manufacturing practices, especially of smaller companies. The database can help India in its attempts to overcome the current regulatory weaknesses within its pharmaceuticals industry.
India plays an important role in the global pharmaceuticals and vaccine industry, being the largest provider of generic medicines globally. The country has a share of 20 percent in the global supply volume and contributes to around 60 percent of the global vaccines. India ranks third in the world in terms of volume and is the fourteenth largest in terms of value. Key segments of the Indian pharmaceutical industry are over-the-counter medicines, generics, Active Pharmaceutical Ingredients (APIs), vaccines, biosimilars, and custom research manufacturing (CRM). India majorly exports drug formulations and biologicals, and these products contribute to about 75 percent of the total pharmaceuticals exports out of India. All this makes it more imperative to leave no room for laxity in regulating this USD 50 billion industry.
According to an office memorandum by the Drug Controller General of India (DCGI) dated October 27, 2022 titled “Constitution of a Committee for preparation of National Drugs Database”, a panel of seven members has been formed to create this database. Such a database is expected to not only empower consumers but to also improve the monitoring mechanism for the quality of drugs in circulation across the country and to ensure uniform administration of the regulatory system. The new database would maintain names, addresses and licences of all manufacturers, therapeutic categories of their medicines, and details like their dosages and forms
The members of the panel include Dr HG Koshia, Commissioner of Food and Drug Control Administration (FDCA), Gujarat, Dr Pooja Gupta from AIIMS, New Delhi, Dr Jerian Jose, scientist at the Indian Council of Medical Research, New Delhi, DR Gahane, Joint Commissioner of Food and Drug Administration (FDA), Maharashtra, BT Khanapure, State Drugs Controller, Karnataka, and Navneet Marwaha, State Drugs Controller, Himachal Pradesh. AK Pradhan, Joint Drugs Controller of India, will be the convener of the panel. The committee will co-opt any other expert as deemed necessary and is expected to submit its recommendation including the database of the formulations in next three months.
Currently there is no comprehensive, real-time information on medicine makers in India, thus posing serious challenges in ensuring the quality of drugs being supplied within and outside of the country. A national database has become important also because many states have their own databases on different software and all that data needs to be integrated into a centralized database.
Currently, the Ministry of Health and Family Welfare maintains “Sugam”, an index of drug licenses issued to companies by state FDAs, while drug prices regulator National Pharmaceutical Pricing Authority (NPPA) separately collects data from companies on companies for price control. SUGAM is e-Governance system to discharge various functions performed by CDSCO under the Drugs and Cosmetics Acts, 1940. The software system developed is an online web portal where applicants can apply for NOCs, licenses, registration certificates, permissions and approvals. It provides an online interface for applicants to track their applications, respond
to queries and download the permissions issued by CDSCO. It also enables CDSCO officials
to process the applications online and generate the permissions online and generate MIS
reports.
Availability of a national database is required from the policy planning and monitoring aspect. It will have the below benefits:
- Digitization would enable better sharing of information between regulators in all states and the centre.
- Regular data collection and sharing will provide near real-time and comprehensive information to the authorities
- The data will be used for various functions, including taking stock of manufacturers producing Active Pharmaceutical Ingredients (API).
- New software will take care of the transition and reform the way drugs and the pharmaceutical sector is monitored and managed.
- Regulators will become more vigilant to act on problems of drug shortages and quality issues.
- Regular online inputs and updates regarding companies, their facilities, and the status of their products will be made mandatory for manufacturers to disclose.
- The database will help restrict the manufacture or sale of specific banned medicines.
The implementation of regulations has been a challenge with the presence of over 3000 odd pharma companies and over 10,500 manufacturing units, leading to ineffective policing and gaps in quality monitoring.
The government also recently launched the Sixth Edition of the National Formulary of India (NFI). The NFI has been published by Indian Pharmacopoeia Commission (IPC) to promote the rational use of medicines in the country. NFI, 2021 is expected to act as a guidance document for healthcare professionals such as clinicians, pharmacists, nurses, dentists and will play a crucial role in daily clinical practices.
Formulary is a manual containing clinically oriented summaries of pharmacological information about selected drugs. The manual may also include administrative and regulatory information pertaining to the prescribing and dispensing of drugs. A national formulary generally concentrates on available and affordable medicines that are relevant to the treatment of diseases in a particular country. Formularies are also frequently created for different levels of health care, different sectors and for individual hospitals. In the past three decades there has been a vast expansion in the range of new drugs and their formulations. To address the need of publication of an updated version of NFI, the MoHFW assigned this mandatory responsibility to the Indian Pharmacopoeia Commission (IPC) and hence the NFI is being published by the IPC on the behalf of the MoHFW.
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References:
https://www.nytimes.com/2022/11/03/world/asia/india-gambia-cough-syrup.html
https://www.nhp.gov.in/drugs-and-pharmaceuticals_pg
https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1767300
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf