In almost all countries, the government is assuming a bigger role in ensuring a healthy supply of quality pharmaceutical products at reasonable prices. This, in turn, leads to an ever-growing importance of regulatory frameworks. There have been rapid changes at the global level, largely related to good practices in research and manufacturing, and clinical and laboratory practices. There are regulatory bodies entrusted with the approval, production and marketing of quality pharmaceutical products at reasonable prices. Many players now seek international regulatory approvals from agencies such as US-FDA, MHRA UK, TGA Australia and MCC South Africa, in order to market/ export their products, mostly generics, in those markets.

Pharma regulation

In India, regulation of pharmaceuticals mainly revolves around quality control, price control and IPR protection. The Central Drug Standards and Control Organisation, 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; regulates the market authorisation of new drugs and clinical trials standards; supervises drug imports; and approves manufacturing licences.

The National Pharmaceutical Pricing Authority, under the Department of Chemicals and Petrochemicals, fixes or revises prices of decontrolled bulk drugs and formulations at judicious intervals; periodically updates the list under price control by including/ excluding drugs according to guidelines; maintains data on production, exports and imports, and market share of pharmaceutical firms; and enforces and monitors availability of medicines in addition to providing the Parliament inputs on issues pertaining to drug pricing.

Spurious drugs

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 Fertilisers is on industrial policy. Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of State authorities, while the Centre is responsible for approval of new drugs and clinical trials, laying down standards for drugs, control over quality of imported drugs, coordinating activities of the State Drug Control Organisations, and providing expert advice on uniform enforcement of the Drugs and Cosmetics Act.

Drug Controller General of India is responsible for approving licences of specified categories of drugs such as blood and blood products, IV fluids, vaccine and serums. In the absence of transparent licensing procedures, the market is flooded with counterfeit and substandard drugs. The Mashelkar Committee report referred to a WHO study that declared that nearly 30 per cent of the Indian market was flooded with spurious or substandard drugs. The Government’s own estimates put it at 8-10 per cent for substandard drugs and 0.2-0.5 per cent for spurious drugs.

Clinical trials

The country has, in recent years, positioned itself as a major player in clinical trials. Its recognition as a centre for clinical trials arises mainly through contract services provided to international players in the form of clinical development services. For efficient and ethical growth of the clinical trials industry, there is need for a strong centralised regulatory regime to enforce guidelines and ensure transparency in the functioning of institutional ethics committees.

Regulatory bodies in India face challenges such as proliferation of substandard drugs; lack of transparency in licensing procedures; inadequate regulatory expertise and testing facilities to implement uniform standards; inadequate support for small-scale firms to enable speedy standardisation of drug quality; need for clarity on patentability of pharmaceutical substances and conditions under which firms can apply for compulsory licences to avert legal battles between local firms, MNCs and civil rights groups; need for greater coordination, accountability and transparency in the functioning of various ministries concerned with drug regulations and so on.

Pre-launch checklist

For a typical player in the pharmaceutical sector, the regulatory compliances at pre-launch stage include developing a molecule keeping in sight product patents and process patents, developing the product as a bio-equivalent of the innovator’s product and scaling it up to commercial-batch sizes, getting regulatory approval for using the Active Pharmaceutical Ingredient (API) to make the formulation, documenting the processes adopted, and, finally, getting the Manufacturing Authorisation (MA) and approval for the manufacturing plant in the country where the product would be marketed.

Generally, most regulatory authorities insist that the MA should be applied for and held by an entity registered in that country. At the post-launch stage, the company should get the plants periodically inspected by regulatory authorities, manufacture the product according to the approved specifications of the respective country, ensure that transportation and storage follow the specifications developed during product development, put in place a pharmaco-vigilance system, periodically conduct stability studies, respond to market complaints and have a recall system for defective products, intimate the regulatory authority on changes including sources of RM/ API/ process/ batch sizes, periodically update dossiers according to changes in guidelines, and so on.

(Gaurav Shah is Partner, Deloitte Haskins & Sells)

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