Drug controller general GN Singh answers questions in an email interview with Pankaj Kumar:
Much is made about your statement that India’s pharmaceutical industry would be closed down if we apply US standards. Do quality standards vary from country to country?
The quality of drugs manufactured in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. These statutes are updated from time to time so that they are responsive to the aspirations and requirements for ensuring quality of the drugs marketed in the country. The provisions are adequate to regulate the import, manufacture, distribution and sale of drugs in India. To secure uniformity throughout India in administration of this Act, the central licence approving authority, i.e. DCGI, and state drug controllers are working together to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs manufactured and marketed in India based on the prescribed standards through enforcement and implementation of the statutory norms. The manufacturers are required to comply with the Good Manufacturing Practices [GMP] as prescribed under Schedule M to the Drugs & Cosmetics Rules.
There are about 49 Standards Writing Institutions across the globe which set drug standards for their respective countries based on technological development, economical situation and regulatory framework of that country. The GMP enforced in different countries may vary as each country is having its own platform for evaluating the safety, efficacy and quality of medicines for its population based on WHO Technical Report Series updated regularly where they participate as Member States.
In India, the government set up the Indian Pharmacopoeia Commission in 2009 to set standards for drugs. The commission is updating standards of drugs manufactured and marketed in India by active involvement of subject experts and stakeholders. The recent version of the Indian Pharmacopoeia (IP) has been published in 2014 which will come into effect from April 1.
The standards to be complied with by the drugs manufactured/marketed in the country are specified in the Second Schedule of the Act. As per the Schedule, the drugs included in the IP are required to comply with the standards of identity, purity and strength specified in that Pharmacopoeia. Whereas the drugs not included in the IP are required to comply with the standards of identity, purity and strength specified in official pharmacopoeia of any other country and such other standards as may be prescribed.
On the pattern of the IP, many other countries have their own pharmacopoeia, for example US Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (PhEu.), Japanese Pharmacopoeia, Chinese Pharmacopoeia, etc.
Therefore, we have to agree that the standards of drugs vary from country to country based on its specific needs and levels of economic development. However, it would also be pertinent to mention that in India, safety, efficacy and quality, which are fundamental components for the Indian regulatory framework, are kept in consideration while setting the standards or enforcing the statutory provisions for ensuring drugs availability for Indians. We work on the principle of providing high quality drugs at affordable price.
After the US FDA red-flagged a series of Ranbaxy plants, what measures have you taken to check or review quality control?
As and when quality issues relating to Indian drug manufacturers are raised especially from the countries which have well-developed regulatory structures, due cognisance is taken by the office of DCGI. The manufacturers have been asked that when such quality related issues are raised by the regulatory authority of a particular country, the same should be brought to the notice of the respective state drug regulatory authority and the office of DCGI so that suitable measures are taken to assess the quality of drugs manufactured and marketed by the company under reference.
The office of DCGI, in the specific case of Ranbaxy, took immediate steps by conducting joint inspections of their manufacturing facilities. Samples of drugs moving in the market were also evaluated for their quality. Based on the inspection reports, the firm has been asked to comply with the regulatory observations made by the inspecting team. The firm has reported that they are taking corrective and preventive measures for compliance with the requirements of the GMP prescribed under Schedule M of Drugs & Cosmetics Rules, 1945. We are expecting that, except the Toansa plant, all other reports of samples and compliance report would be evaluated by March 2014. The Toansa unit has been put under surveillance by the Indian regulator.
The Indian market is scared over the quality of drugs after the US FDA action. What do you have to say to your Indian customers?
The mission of the CDSCO [Central Drugs Standard Control Organisation] is to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices. For this purpose, the drug regulatory infrastructure in the centre as well as in the states, including drug testing laboratories, is being strengthened under the 12th five-year plan. Samples are drawn from the manufacturers as well as market to test the quality of the drugs marketed in the country. The Drugs & Cosmetics Act was amended to enhance the penalties and to make certain offences non-bailable. As and when any non-compliance is reported either at the centre or state level, immediate steps are taken for recall of the medicines which are not found to be of standard quality. The prosecutions are filed against the erring organisations/individuals. About 16 special courts have been designated for such cases.
India is supplying medicines to more than 200 countries and they have been granted permission in the respective country after rigorous regulatory evaluation in terms of quality and safety parameters. I can assure the Indian consumers that products moving in Indian trade are of high quality, meeting quality standards. As a regulator, we are keeping a close vigil on quality of the medicines moving in Indian trade in close coordination of CDSCO officials and state regulatory personnel.
As India’s drug controller, how much credence do you lend to accusations of the drugs contaminated by flies and hairs?
As a regulator of this country, we are committed to enforcing regulatory requirements of GMP and product quality as per the label claim. Violation of provisions of the GMP on standards is viewed seriously by the Indian regulator. The presence of foreign particles like flies or hairs are not acceptable at any stage of manufacturing product and due action is taken if such violations are noticed.
India’s pharmaceutical industry has emerged as a force in the global market. What is the impact of such accusations on the industry internationally?
The Indian pharmaceutical industry has modern manufacturing facilities complying with the regulatory requirements of a highly regulated market. Scientists/technocrats working in particular pharmaceutical units are aware of the national and international regulatory landscape and they are constantly upgrading their facilities to match the current safety parameters as per the international guidelines. Today we have about 360 US FDA compliant plants and more than 1,600 WHO GMP compliant plants. About 6,000 units which are manufacturing drugs in India are complying with the basic requirements of the GMP as prescribed in Schedule M of Drugs & Cosmetics Rules, 1945. Units not complying with the requirements are seen as cases in isolation. Overall, the pharma sector is seen as a success story at the global level and there is scope of improvement as per current technological developments which Indian industries are capable enough to adopt. We see a huge market and potential of penetrating the new market segment.
Some people see a conspiracy against Ranbaxy behind the recent actions.
I do not see any such thing nor has anything come to my notice. The Indian pharma sector would take this as an opportunity to further improve its compliance of the GMP as required internationally and comply with the requirements of statutory provisions of the land. I believe that tough situations provide opportunity for delivering better products and services. We should not forget we are in the health sector and safe and efficacious medicines are the right of the patients.
Will the action against Ranbaxy hamper the growth of the Indian generic market?
The pharma sector is emerging as a global pharmacy of the world. As and when you are moving from national to international marketing environment, you have to adapt to the environments of the country where your product is moving or you intend to enter. I believe that the present focused approach by regulatory authorities could provide a platform for Indian manufacturers to consolidate and improve upon their facilities to comply with national and international regulatory practices. Realising that India’s strength is in the knowledge and technical competence, I am of the firm belief that the pharmaceutical industry would be able to face the current challenges and enter an era where growth of the sector would get boost by passing through this transforming phase.
Any plans to upgrade the regulatory mechanism in view of the US FDA action?
We have a Statement of Intent with the US FDA and working arrangement between the two regulatory authorities. It would provide the right platform to know and understand the regulatory requirements of that country so that we are able to harmonise our regulatory practices without compromising on the philosophy of providing medicines of high quality at affordable prices.
The government of India is aware that there is a need to upgrade the regulatory mechanism under the 12th five-year plan. Mega steps have been envisaged by allocating funds of '3,000 crore, out of which '1,800 crore would be utilised for capacity building of the central regulatory framework and '1,200 crore for strengthening regulatory system of the states which play an important role in regulating manufacturing and sale of drugs in the country. Emphasis has been put on establishing new drug testing laboratories and upgrading the existing facilities so that the evaluation of quality takes place on a faster track. Special courts have been set up for disposal of prosecution cases promptly so that people involved in clandestine activities are punished.
Is the shortage of drug inspectors a factor in quality control as well as in checking irregularities in over-the-counter sales?
In India, we have 8 lakh supply chain outlets, some of which have qualified and trained pharmacists who strictly comply with the requirements of Schedules prescribed under the Drugs & Cosmetics Rules, 1945 keeping in view the patient’s safety. In the 12th five-year plan, the manpower and infrastructure both at the centre and state levels are proposed to be enhanced so that an adequate number of drug inspectors are available to monitor the sale of drugs in the country to ensure that prescription medicines are not sold without prescriptions.
Is the Indian pharmaceutical industry hit by non-clearance of files owing to strict norms of clinical trials? How do you propose to address it?
In recent years India has consolidated its manufacturing base by having state-of-the-art manufacturing facilities and establishing its brand by providing generic medicines of high quality at affordable prices to more than 200 countries. Now the industry and its scientists/technocrats are striving to enter into the drug discovery research area which requires high investment. The clinical trial is one of the components of drug discovery research, which requires to be properly addressed in this country.
In recent years, the government has taken various measures for ensuring the safety, rights and well being of the trial subjects which have been reported to be exploited earlier. I can tell with certainty that now procedures have been put in place to provide a conducive environment for conducting clinical trials in the country without compromising the patient safety.
In nutshell, I would like to assure that in a few years, the Indian drug regulatory system would be a benchmark system for many countries to follow. This benchmark would only be possible by general awareness of the public, commitment of the regulatory authorities and investments by the government of India in strengthening the drug regulatory framework of the country. n
