Need for a policy framework around Pharma

A recent media report of several patients losing their eyesight as a result of use of an off-label drug to treat certain retinal disorders like age related macular degeneration (AMD) reflects the abysmal condition of the regulation of the pharmaceutical sector of India. Many similar drugs are making circulations in the country without their proper generic origin. In simple words, this situation points out that most medical products in India have not complied with the mandatory guidelines but reach the consumers unhindered.

What is the current status of Medicine in India?

India is an emerging country in terms of its medical tourism. Currently, this sector has been facing a growth of 22-25%, the value of which is being estimated at $ 6 billion for this year. There has been an initiative jointly by the ministries of health, tourism and culture and external affairs to increase the number of medical tourists.

However, the abysmal condition has arisen due to the non-effort by the government to improve the domestic medical healthcare. Taking up the case of retinal disorder, there are several biosimilars of the generic drugs for retinal disorders. These drugs are cheaper than the generic ones but vary considerably from the original ‘innovator’ drug. They can be regarded as the duplicate copies of the original, without any verification by the authorities about their suitability. It is undeniable that a small change in the composition of a drug can have a drastic difference of effect on the body of the person. But since the generic drugs are difficult to replicate as they are made using living cells and with certain level of molecular complexities, the biosimilars display a major change in the molecular complexities. However, these are not scrutinized, jeopardizing patient safety to a huge extent.

What are the mechanisms for scrutiny in India?

The Drugs and Cosmetics Act, 1940 and Rules, 1945 is the legal framework with regard to this. The power to amend the Act and the rules has been given to the Central Drugs Standards Control Organization. There are others like the Pharmacy Act, 1948, Drug and Magic Remedies Act, 1954, Drug Prices Control Order, 1995 and other policies framed by the Department of Chemicals and Pharmaceuticals. The Act provides for a dual regulatory control at the Central and state government. The responsibility of central authority includes approving new drugs, standard setting, control over imported drugs, coordination of state’s activities and clinical trials. The state authorities issue license, monitor manufacture and regulate the distribution and sale of drugs. The three major policies include: Drug Policy 1986, Pharmaceutical Policy 2002 and National Pharmaceuticals Policy 2006.

In order to enforce a detailed policy regulating drugs, the Department of Biotechnology and the Central Drugs Standard Control Organization framed the ‘Guidelines on Similar Biologics: Regulatory Requirements Marketing Authorization in India for Biosimilar Drugs’. But the guidelines are neither followed nor implemented properly.

What are the discrepancies in the aforesaid guidelines?

Some of the major drawbacks in the established guidelines are:

• The guidelines do not mandate the supply of clinical data for every indication for getting the approvals, which is an essential part of a drug. Ignorance of this allows mishaps like the ones mentioned above.
• There is no pharmaco vigilance at every level like for regulators, drug companies, medical practitioners and patients separately, which is a need of the hour.
• There is no stipulation as to patient safety guidelines and strict regulatory approval framework for preventing the existing malpractices.
• There is no provision for sufficient Nationally Accredited Laboratories (NABL) for frequent and regular tests.
• There is no mechanism to check whether the manufacturing units comply with the Good Manufacturing Practices and the Good Laboratory Practices of the WHO.

What is the Draft Pharmaceutical Policy, 2017?

This draft has been drawn in the light of the National Health Policy 2017 that has huge implications on the pharmaceutical sector. Some of the immediate concerns it seeks to address is the high dependence on import of drugs and on the drug security. It will also address the quality surveillance of the indigenously manufactured drugs for domestic consumption.

Some of the new initiatives are:

• Making Bio-availability and Bio-equivalence tests mandatory for all drug manufacturing permissions by the State or Central Drug Regulator for the purpose of quality control. It is mandatory for future renewal of manufacturing licenses also.
• Enforcing the GMP and GLP of the WHO. It will first be implemented for the procurements out of the National Health Mission Funds and then for the small scale industries in a phased manner.
• Shortening the approval process of the drug regulators and standardizing them. A decision on an application shall be within a period of 3 months and extendable upto 3 months by the Chief Drug Regulator for reasons recorder in writing.
• Giving brand names to generic drugs will not be allowed. Public procurement is only ti be made of generic drugs in their salt names. So, sale of single ingredient drugs will be encouraged.
• To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerised and the medicine name will be picked up from a drop down menu of salt names.
• Principle of ‘one manufacturer, one brand name and one price’ shall be implemented.
• A database will be created for the pharmaceutical sector.

Further, there has to be compulsory provision of static bar code which will contain price information of the drugs.