The recent World Bank’s Doing Business Report 2018 ranked our country at 100 out of the 190 countries surveyed. The 30 places jump of over last year ranking of 130th is a satisfying improvement. It is satisfying because India has shown more improvements in last couple of years compared to other BRICS countries though its ranks is lower than that of Russia, China and South Africa. Among the BRICS countries, India is just ahead of only Brazil. In order to improve further, several initiatives are required from policy level to regulatory changes to build up confidence among the business communities or investors. In addition to three important issues of concern identified for reforms: land ownership, labour laws and judicial process; it is also necessary to have significant reforms to avoid bureaucratic delays and improve transparency in the process to eliminate corruption.
On the line of ‘make in India’ initiative to facilitate pharmaceutical business, the government has taken steps to review the existing regulations and bring reformation. It is just to mention two recent efforts of the government: Removing the validity of the license for manufacture and sale of medicines; and smoothening the process of pharmaceutical imports.
The Government of India’s gazette notification on October 27, 2017 removed the words ‘renewal’ or ‘renew’ from the Drugs and Cosmetics Act and Rules, the main regulation deals with the medicines. It made the licences in perpetuity to pharmaceutical companies and retail pharmacies scrapping the existing policy of renewal of licences every five years. The licence will remain valid if the licensee deposits the retention fees before the expiry of a period of every succeeding five years from the date of issue. The licensee has also option to pay the retention fees with fine up to six months of the date of expiry of licence. There is a provision for inspection and this inspection is to be conducted jointly by the central and state government to verify the conditions of licence and compliance. The inspection to verify compliance with the licence is to be conducted at least once in three years or as the risk perceived for pharmaceutical companies. The licenced sales premises are also be inspected at least once in three years to verify the compliance of license conditions, but the inspection is by state’s drugs inspector. This amended provision not only encourages the manufacturers and traders to make their business hassle free, it would also remove the corruption.
In a recent memorandum issued to port offices, the Central Drugs Standard Control Organization, clarified that products must not be held back for minor confusions or mistakes in paper work if importers are holding valid registration certificate and import licenses. This has been viewed as a significant step of the government as around 70 per cent of the pharmaceutical active ingredients are imported for generic formulations in the country. These clarifications are not only intended for smoothening the import process for ease of business, they are also part of promoting patient safety and enforcing regulatory compliance.
The government is also concerned about public health aspects of pharmaceuticals especially when the Prime Minister openly urges for promoting generic medicines. In an attempt to build public confidence as well as confidence of healthcare professionals on generic medicines, the Government of India, has notified the requirements of bioavailability and bioequivalency in pharmaceutical products. A notification dated April 3, 2017 made the acceptance of Biopharmaceutical Classification System of Drugs (BCS) and mandated the bioequivalence test data for oral dosage forms. The manufacturers need to conduct the bioequivalence study as specified in Schedule Y of Drugs Rule and submit the data seeking license for solid dosage forms of category II and category IV drugs. Category II indicates drugs of low solubility and high permeability; and Category IV means drugs of low solubility and low permeability. Bioequivalency results not only ensure brand to brand to generic substitution, but also ensure batch to batch quality.
There have been some disturbing trends too. Several pharmaceutical companies who are exporters to developed countries received warning notices from respective regulatory authorities on quality issues. These warning letters range from raising serious issues like data integrity, often submitting data without testing, to procedural issues and quality of products. Many products have been withdrawn from market when the regulatory authorities find the products are not satisfying the quality parameters of the country. This definitely damage the country’s reputation. The USFDA, EMA, and other agencies at different times find the quality issues or non-compliance with regulatory requirements. The Indian regulatory system has to take a pro-active approach not to allow the faulty companies continue their bad practice and ensure that other companies comply with regulatory standards before being allowed to export. The export of pharmaceuticals is the main revenue generating source for Indian pharmaceutical companies. Damage caused by one company adversely affect the prospects of others.
Unlike other sectors of business, the pharmaceutical business is always more regulated as it is directly concerned with the health of the people. Throughout the world and more specific to the developed countries, the regulations and regulatory authorities focus on protecting the public health through ensuring availability and affordability of quality pharmaceutical product. In spite of all stricter regulations and stricter vigilance, the drug tragedy and poor quality continue to be a cause for concern. While some of the steps taken by the government like making the licence for manufacturing and sale of medicines for unlimited period of validity to promote pharmaceutical business, it is perhaps equally important to have mechanisms to prevent unscrupulous business from damaging India’s reputation of supplier of quality generic medicines to the rest of the world and protecting the health of the people of the country by preventing the entry of ‘not of substandard quality’ pharmaceutical products. A regulatory balance is necessary between the reformation in the line of ‘make in India’ initiative to facilitate the ease of doing business and assurance of safe, effective, quality and affordability of pharmaceutical products.
(The authors are faculty, Department of Pharmacy, Annamalai University, Annamalai Nagar )