The sole role of a regulatory and legal cluster involves the development and execution of strategies to ensure effective drug development by the team and meet global guidelines. In addition, regulators also ensure that the newly developed drugs are competitive in the pharmaceutical sector, and the company’s activities meet global standards as well as national standards of operations including sale and promotions. The regulatory and legal cluster is also commonly termed as the regulatory affairs team.
The main legislation governing drug registrations, import, manufacture, distribution, and sale in India is followed by the Drugs and Cosmetic Act (Ministry of Health and Family Welfare, 2014). Furthermore, the Central Drugs Standard Control Organization (CDSCO) is responsible for administering and regulating drug registration, manufacture, and sales (Lee et al., 2015). On the other hand, the Drug Controller General of India (DCGI) is responsible for looking after the complete pharmaceutical operations and ethics along with the formation of policies. The regulatory and legal cluster has important functions in the pharmaceutical ecosystem that helps the pharmaceutical businesses to grow.
Role of the regulatory and legal cluster in the drug approval process
The main responsibilities of the regulatory and legal cluster in the drug approval processes include;
- Quality control and assurance of drugs and pharmaceutical products.
- Approvals and compliance of clinical trials.
- Good practices in manufacturing, laboratory and clinical.
- Patents and intellectual property rights.
- Drug production and marketing.
The drug approval process in India
The following image shows the complete process of the pharmaceutical drug approval process in India.
A drug that is produced newly requires approval by the CDSCO and this process involves three steps (Lee et al., 2015). The first step is an examination by the drug division to make sure that the drug meets the safety guidelines and efficacy of the drug. However, after the approval, clinical trials can perform for checking the efficacy and kinetics of the drugs.
They are divided into 3 phases and each phase looks after the standards of efficacy, safety and optimal dosage (McGettigan et al., 2015). Once the clinical studies for the drug are completed, an application to the concerned body or authority is submitted for approval to the DCGI and CDSCO. DCGI and CDSCO review the application and may approve the drug for marketing.
Clinical trials mainly use humans for testing to check the presence of a pharmacological effect. The National Drugs Advisory Board, along with CDSCO and DCGI has set up various guidelines like the Drug and Cosmetics Act so that the pharmaceutical companies follow these guidelines for successful clinical trial approvals (Mishra & Chaturvedi, 2015).
The duty of the members associated with regulations and legal compliances does not end with drug approvals. Their duty starts from pre-clinical phases to marketing phases and related legal conflicts (McGettigan et al., 2015). Thus, it may be implicated that regulatory and legal cluster hovers over the complete operations of a pharmaceutical company.
Role of the regulatory and legal cluster in pharmacovigilance
Pharmacovigilance, a phase IV clinical activity of checking the quality of medicine, negative drug reactions, and errors. However, in many instances, drugs made available to the market after successful phase III clinical trials have seen medication errors and adverse drug reactions. It is estimated by the European Medicines Agency, (2018) that on average approx. 10 million people die from medication errors globally and adverse drug reactions costing average losses of around USD 50 billion. Therefore, bearing the losses and costs is the responsibility of the pharmaceutical company. In addition, the role of the regulatory cluster in this aspect is to see that the drugs available in the market causing adverse effects are brought down and effective actions are considered.
It is the duty of the regulatory cluster to monitor the efficiency and safety of the drugs post commercial production approval. Moreover, it is also the duty of the regulatory cluster of any pharma company to keep in touch with the healthcare centers administering new drugs to patients (Patravale et al., 2016). The regulators also remain responsible for reporting the significance of the newly developed drugs to healthcare specialists, paramedics, doctors, and nurses to improve pharmacovigilance. In addition, the regulator holds the capacity in withdrawing market authorization, recalling medication, distribution controls, and product handling to avoid massive human losses and financial setbacks to its company.
For instance, adverse drug reactions were observed with Ajovy, a type of migraine drug was reported to be mostly mild to moderate. ADRs of Ajovy included short-lasting skin reactions, mainly at the injection site and comprises of pain, hardening of the skin, redness, itching, and rash at the injection site. However, the company pulled back its drug from the market and reworked on the reduction of ADRs.
Factors affecting good regulatory practices in pharma industry
Regulators and auditors of the pharma industry must see that scientific knowledge remain appropriately used along with the preparation of reports according to international standards (Patravale et al., 2016). The regulatory office also needs to maintain consistency of regulatory guidelines and laws for appropriate and ethical functioning of pharma-related operations. The good practices in the regulatory cluster also include the efficient following of the regulations by adhering to technical and standards of drug production. The regulatory good practices also include transparency, which is the key to gain public trust as well as that of stakeholders and government auditors (Patravale et al., 2016). Lastly, it is also very important that regulatory agencies and pharmaceutical organizations maintain collaborations in the development of safe and new drugs. All these factors of good practices by the regulatory cluster in a pharmaceutical company make them the guardians.
- FDA. (2016). Drug Recalls. Available at: https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm (accessed on 4-2-2019).
- FDA. (2019). Importing CBER-Regulated Products into the United States. Available at: https://www.fda.gov/ (accessed on 4-2-2019).
- Lee, S. L., Saluja, B., García-Arieta, A., Santos, G. M. L., Li, Y., Lu, S., … & Purandare, S. (2015). Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J, 17(5), 1285-1304.
- McGettigan, P., Roderick, P., Mahajan, R., Kadam, A., & Pollock, A. M. (2015). Use of fixed dose combination (FDC) drugs in India: central regulatory approval and sales of FDCs containing non-steroidal anti-inflammatory drugs (NSAIDs), metformin, or psychotropic drugs. PLoS medicine, 12(5), e1001826.
- Ministry of Health and Family Welfare. (2014). Drug and Cosmetics Act. Available at: http://www.medindia.net/indian_health_act/drugs_and_cosmetics_act_1940/list-of-acts.htm.
- Mishra, S., & Chaturvedi, V. (2015). Are western guidelines good enough for Indians? My name is Borat. Indian Heart Journal. 67(2), 85-89. https://doi.org/10.1016/j.ihj.2015.04.001.
- Patravale, V. B., Disouza, J. I., & Rustomjee, M. (2016). Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs. CRC Press.
- Pharmaphorum. (2019). Teva’s migraine drug Ajovy looks set for EU approval. Available at: https://pharmaphorum.com/news/tevas-migraine-drug-ajovy-looks-set-for-eu-approval/ (accessed on 9-2-2019)
- Torjesen, I. (2015). Drug development: the journey of a medicine from lab to shelf. Pharmaceutical Journal.
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