The Indian Government and other pharmaceutical authoritative bodies like CDSCO, ICMR and CSIR, regulate the pharmaceutical industry in India (Indian Pharmaceutical Association, 2017). They are responsible for policy making, quality checking, and regulations of drug manufacturing and drug marketing. These institutions, therefore, act as both challengers and motivators of the pharmaceutical sector and the allergy drug market. Unlike international organizations monitoring exports of drugs, these organizations regulate the drug industry. Regulation of complete drug industry starts from raw material procurement to final production, packaging, and certification.
Organizations involved in regulating the pharmaceutical sector of India
There are several organizations that regulate policy formation and programmes governing the pharmaceutical sector. The policy formation for the regulation and development of the pharmaceuticals consists the decision from both the sectors i.e. government sector and private sector (Indian Pharmaceutical Association, 2017). Department of Pharmaceutical (DoP), Central Drug Standards Control Organization (CDSCO), Indian Council of Medical Research (ICMR), and the Council of Scientific and Industrial Research (CSIR) are the main regulatory bodies of drug manufacturers. The decision making bodies of both government and private sectors are given below:
Importance of policies in regulating the drug market
Government policies allow the pharmaceutical market to protect their drug innovations as well as control the quality of the drugs. These policies also allow small drug enterprises for a joint venture with larger operators as they do not have the financial capacity to substantially upgrade their plants and equipment or to target a larger market. Policies also engage regulatory controls on manufacturing facilities, inspection of plants, quality control, and clinical reports (Indian Pharmaceutical Association, 2017). CSIR and CDSCO, however, remain in cooperation with the USFDA for a positive development of the pharmaceutical and allergy drug market.
Government policies also focus on the quality of the products produced by the drug market. Policies also look that the drugs failing clinical reports are banned for sale until the next update of the drug. For instance, two allergy drugs i.e. terfenadine & astemizole were banned from India in accordance with the Drugs and Cosmetic Act because these drugs cause harm to the liver and heart of the people taking them.
Role of the Indian government in driving the drug market
The government makes policies to control the development and sale of drugs. Allergy drug market in India constitutes 10% of the total pharmaceutical market. Therefore, checking each type and category of the allergy drug remain essential before commercial production. Government associations like CDSCO and Pharmaceutical Export and Promotion Council of India, take care of various allergy drugs, their packaging, composition of the drug and their sale (Mondaq, 2017). They make sure that no harmful drug will be passed on to the common public. Therefore, the government policies act as both the challenge and the motivation for the allergy drug market (Rägo & Santoso, 2008).
The rules and regulations are tough due to the efficient drug policy-making organizations like FDA and CDSCO. These organizations monitor each step right from the formation of the drugs to its packaging and labelling. If any of the steps are not properly followed by the pharmaceutical companies then the drug remain banned for sale and even receive warning letters (Rägo & Santoso, 2008). This causes sales and performance-based losses to the industries. Therefore, the regulation challenges the manufacturing practices of the pharma industries. Improved regulation constitute increased expenditures for manufacturing of drugs, which acts as a challenge to smaller industries.
Government regulations motivate the drug market
The Drug Consultative Committee is formed under the Drug and Cosmetic Act. It mainly regulates the sales of the drugs in the market. The regulations made a revolutionary decision of OTC (over the counter) drugs, whereby the common allergy drugs remain available to the market and patients without any prescription (Livemint, 2017). It saves the time and money for a lot of industries, especially the smaller industries. Therefore, allowing allergy drugs sale in a large quantity with respect to the increasing prevalence of the allergic diseases in India. Along with its sale in India, there is large demand of the Indian allergy drugs in the international market (Rägo & Santoso, 2008). However, there are International laws that also govern drug manufacturing, quality, and marketing including exports from India also act as challenging and motivating.
- Indian Pharmaceutical Association. (2017). Regulations & Guidelines. Retrieved October 5, 2018, from http://www.ipapharma.org/regulations.aspx
- Livemint. (2017). OTC medicines: Drug advisory body gives in-principle approval. Retrieved October 5, 2018, from https://www.livemint.com/Industry/JDBw98u6FtlK53BF2I7i7I/OTC-medicines-Drug-advisory-body-gives-inprinciple-approva.html
- Mondaq. (2017). Drugs And Cosmetics (Tenth Amendment) Rules, 2017. Retrieved October 5, 2018, from http://www.mondaq.com/india/x/668426/food+drugs+law/Drugs+and+Cosmetics+Tenth+Amendment+Rules+2017
- Rägo, L., & Santoso, B. (2008). Drug regulation: history, present and future. Drug Benefits and Risks: International Textbook of Clinical Pharmacology, revised 2nd edition, 65-77.