You can safely pop a pill and feel better because the drugs prescribed for you have been tested and declared safe and efficient by the Central Drugs Standard Control Organisation (CDSCO). The head of the apex drug regulation body is obviously, a busy person, compelled to shuttle often between his office at FDA Bhawan in the capital and the Union ministry of health and family welfare at the Central Secretariat, not too far away.
The Drug Controller General of India,
G.N. Singh’s mandate is to safeguard the quality of the more than Rs 2 lakh crore worth of medicines and vaccines that India’s pharmaceutical industry produces. He inspects and regulates over 7,000 drug manufacturing companies in India.
These companies are both domestic suppliers and exporters of bulk drugs and pharmaceuticals to more than 200 countries. Singh told Himani Chandna that after easing rules to hasten approval for HIV and Hepatitis drugs in the country, he now planned to relax procedural norms for drugs for other deadly diseases, like cancer, tuberculosis (TB), kala-azar and filariasis.
Edited excerpts.
You have fast-tracked approvals for new combination drugs for HIV and Hepatitis B and C. Do you intend to hasten the process for any other category of drugs?To make new innovations and drug combinations available to patients readily, we are considering hastening the approval processes for anti-Cancer drugs and drugs for Tuberculosis. Moreover, we are studying the national disease pattern and occurrence of rare diseases in India. We may also relax approval norms for new drug applications for kala-azar and filariasis.
The prevalence of not-of-standard-quality (NSQ) medicines at retail outlets across the country is only 3.16 per cent, according to the National Drug Survey 2014-16 of the Ministry of Health and Family Welfare. How do you plan to improve the quality of our medicines further?Ideally, we should look at pruning this number (3.16 per cent) to zero. However, it is almost an impossible task. The rational target is to match global standards, which allow two per cent to 2.5 per cent of NSQ medicines. Over the next two to three years, our goal is to peg down NSQ medicines to just two per cent of our total production.
The United States Food and Drug Administration (USFDA) has recently issued an import alert at Divi’s Laboratories’. In 2015, about 13 warning letters were issued to top pharma companies, including Sun Pharmaceuticals, Wockhardt, Cadila Healthcare and Dr. Reddy’s. How do we plan to tackle the quality concerns raised by international regulators? We have ordered State drug regulators to offer hand-holding to the drug makers — larger multinationals to small and medium enterprises. We have asked drug makers to attain a certificate from the Skill Development Council of India by the end of 2018, which would train each and every employee of the firm.
The objective is to decode terms like good manufacturing practices (casually known as GMPs) for every employee at the organisation. The first step will be soft, careful, hand-holding. Later, we will introduce the harsh measures.
What would the harsh measures be?We will start taking action if the firms do not co-operate with us. It is about the reputation of India, a country known as the pharmacy of the world. If a pharmaceutical firm plans to earn revenues by exporting drugs, it should be ready to serve the quality that global drug regulators demand. If not, they should be ready to face regulatory action, including hefty penalties and even cancellation of manufacturing licences by CDSCO.
How will you select companies for the risk-based assessment programme, which aims at skilling companies to produce efficient drugs?The companies that have received warnings from international regulators (in the past or recently), including Wockhardt and Sun Pharma, are under our radar. Companies failing our sample testing, compliant procedures during inspections or companies observed by our intelligence teams will fall under the training mechanism in the first phase. We have already worked with 40 companies over the last few months and our target is to ensure that at least 150 to 200 companies improvise annually.
How do you plan to ensure regulation of medical devices in the country? We will soon establish a separate vertical dedicated to medical devices under CDSCO. We have designated a few officers and may soon hire inspectors for the department. A Subject Expert Committee has been formed, which is spearheading the plan and forming guidelines on medical devices. We are also reworking on the medical device pharmacovigilance programme.
E-pharmacy startups seem to have swallowed a bitter pill, as India awaits laws governing online sales of medicines. How soon could these companies expect clarity on the issue?I can only say that we are very close to attaining clarity on the matter. We are looking for the safest possible model. I assure you that we will arrive at a decision very soon and we are very serious about making the transition and adopting new technology. It may happen within this year.
himani.chandna@businessworld.in
