The quality control of drugs and pharmaceuticals has never been an easy affair in the country as issues before the drug control machinery pertaining to production and trade of drugs are many and the resource available with this crucial department is limited. Though India is ranked amongst the top three producers of APIs in the world and the pharma industry is the fourth largest in terms of production volume, the country is still passing through a learning curve in many of the vital aspects of regulations. However, the country's drug control mechanism is soon expected to be streamlined in a more systematic frame with a set of new schemes.

Ashwini Kumar, the Drug Controller General of India (DCGI) and the man at the helm of affairs at the Central Drugs Standard Control Organization (CDSCO), has reasons to be defensive on the lapses and allegations charged upon the department. The DCGI, in an exclusive to Chronicle Pharmabiz, spoke to CH Unnikrishnan and Joe C Mathew about the new schemes up in the CDSCO to streamline the drug regulatory services of the country. Excerpts:


Though there are a host of new drug approvals and proliferation of drug manufacturing units coming out with formulations especially FDCs in the country, the mechanism what your department is supposed to have for monitoring adverse drug reaction (ADR) is miserable and almost nonexistent. Why it is so?

Even though the department has a special cell looking after the post market surveillance of the newly approved drugs and dosage forms, it was never very aggressive with lots of limitations. At the same time, I am sure that there were hardly any drugs, not in use in the developed countries for long, which have been approved for use in the country. However, now we are planning to initiate a pharmacovigilance programme to address the ADR issues. As part of the programme 25 to 30 centres in the country will be provided assistance, computers, etc. All these centers will be in medical colleges where meta-analysis can be done. Molecules, either new ones or ones like nimesulide or paracetamol can also be studied here. For creating wider awareness for attracting inputs from practicing doctors, the special ADR bureau would have a website, through which they can feed the inputs online in the given format, and there will be a toll free number to receive these inputs at the centre.

It has a flip side also. Some time, the patient may be suffering from different problems not essentially by the drug reaction and the doctors may not be able to diagnosis properly. However, it is anticipated that the medical fraternity including medical associations would cooperate at their level best to make this effort an effective one. In India, there are various issues, which may hamper the true analysis of market surveillance and also the diversity of patients often makes it a complicated exercise. So we need an Indian version of post marketing surveillance system in place.

Drug R&D and clinical trials are currently a growing area in the country. But, there are lacunae as far as the clearance procedures are concerned. There were even unethical practices reported in various approved trials. How these issues are addressed at the central level?

The current GCP guidelines have taken care of most of the vital issues as far as the clinical practices are concerned. The amendments Schedule Y of the Drugs and Cosmetics Act was towards opening up the new avenues what the country could foresee in the pharmaceutical research and also clinical trials with the emergence of contract research organizations (CROs) here. These amendments and the guideline are expected to bring much-needed discipline and ethics into the practices of clinical trials in the country.

As far as drug research is concerned, the government of India wanted to have a very encouraging scenario here. Barring some stringencies in animal experimentation and related area, the industry and institutions do not find any hassles for going ahead with their projects. The government is also thinking about allowing parallel trials within the country, which is not allowed at present, by necessary amendments in the section soon.

The industry is currently asking for more molecules to be freed from trade regulations in order to promote these drug brands as over-the-counter products and also to make the products available in non-pharmacy stores. Can it be adopted here in order to make availability of drugs in the country especially at the rural areas?

There are considerations to bring better and wider access of certain time tested medicines especially household remedies. It is mainly for rural areas where there are no medical shops for which the existing trade restrictions can be minimized.

The drugs which are not included either in Schedule H or X are already non-prescription medicines. So there are no restrictions for these drugs, as it does not need a prescription to purchase. However, allowing all these drugs into non-pharmacy stores will not be a wise idea. So, some of these products which are known for its safety profile for long can be permitted in specified stores, where a qualified pharmacist would not be required to dispense the drug products.

This may result into encouraging self-medication. However, since our customer awareness is not satisfactory there may have certain directions to the industry to take adequate measures to educate the customer in an ethically right way while promoting those products through unconventional route.

When the industry recently released a guideline for ethical promotion of over the counter drugs, it had submitted a list of more than 50 drugs to be allowed to market as OTC products. Will you consider all those molecules to be promoted in this route?

Some of them can be considered as safer drugs and are likely to be allowed for promotion through nonprescription route. And such products, especially the cough and cold preparations, mild pain management products etc, can also be considered as household remedies and to be sold at the specified non-pharmacy stores.But the department is yet to take a final decision on this.

There was a proposal to bring medical devices under regulatory control. How far the efforts progressed towards this proposal now?

We are planning to have a separate committee under the department. The committee will be in charge of medical devices regulation and will seek the help of expert panels to come out with the essential documents. Indian Council of Medical Research (ICMR) will also be involved. The Defence Research and Development Organisation (DRDO) has prepared a document on the quality of medical devices. It is the only document available right now and we are planning to expand the scope of the document after more discussions. Once the regulatory system is in place, it can be converted into a totally independent regulatory agency.

Counterfeiting or spurious drugs is a social menace and it has harmful impacts on patients as well as genuine manufacturers.It is the responsibility of the drug control department to ensure that no fake/substandard drugs coming into the market. But, how successful is the department to safeguard the public from this menace?

Counterfeiting is a worldwide problem. Strict enforcement of laws is the only way to have a check on this. The Central government has asked all the states to enact strict laws to counter the spurious drug problem in the country. The minister has asked the state governments to consider formation of laws similar to "The Gujarat Prevention of Anti-Social Activities Act, 1985" which provides for preventive detention of drug offenders for anti-social activities and dangerous activities prejudicial to the maintenance of public order.The computerization of the state drug departments, strengthening of drug testing laboratories is all going to help us.

Today it takes almost six months for a drug sample to get tested. The testing time should be reduced to one month. But then we cannot identify the culprit who misbrands a product. It cannot be detected through tests also. So pharma industry needs to come forward to help the department in tracing such elements that are into the manufacturing of misbranded products.

When would be the computerization project to link the Drugs Control Department completely operational across the country?

The computerization of all drug control departments will be over by the end of next year. Already pilot project has started in six states. Chennai, Andhra Pradesh, West Bengal, Gujarat, Maharashtra and Delhi are the ones where trials are to be over within three months. Within a year we will be able to network the functioning of entire drugs control departments. Meanwhile we are organizing national workshops for regulatory officials in various parts of the country.