Indian Drug Regulatory system at the central level is as old as independent India and has remained confined to the office of Drugs Controller of India, mostly without intervention of any other department or Ministry. The progression of this control has been from import of formulations and APIs to manufacture these within the country for own consumption and for few years for export. Internationally India has emerged as a major manufacturing location for supply of generic drugs. Outlook and its directional movement of drug regulatory system has changed from time to time according to expectations form its various chiefs (Drugs Controller of India) those occupied seat at different times. Since its inception the organization that mainly was policy making and rules making organization, for past 15-20 years has transformed into a licensing organization. It has taken zealous steps to move in that direction. Policy making and rules revision process has taken back seat.
Readers will agree that India is exporting good amount of drugs and pharmaceuticals to most of developing and developed countries in the world and these exports from India is a compulsive force to upgrade drug regulatory system. Our DRA might not have thought of any initiative, had there been no such surge in export as it is noticed today.
Efforts are made to change the outlook of the organization and making it appear on par with several other organizations in the world and WHO. Number of initiatives begun at the time of previous two incumbents of the post and are taken further by the present Drugs Controller of our country, who occupied seat almost a year ago.
A long cherished desire of an independent building of Drugs Controller India's office, foundation of which was laid during tenure of Ashwini Kumar, fulfilled when Central Drugs Standard Control Organisation the office shifted to new FDA Bhavan at Delhi as Drugs Controller India's office. Fresh systems and procedures began for quick disposal of applications. This was a demonstration of new initiatives from Indian drug regulatory system. It is not good for an ex- regulatory official to comment if the situations have improved or otherwise. Those who have experienced the clearance of their applications from the office of Drugs Controller, can only comment if the situation in past few months has been good or not so good. In case the clearance is not to expectation, applicants keep guessing their fate of their application and are forced to follow line of personal persuasion.
In case the situations have improved in the office of Drugs Controller India, sustainability of the procedures by its administration will be a tight rope walk. If skilful balancing is done, the walk will be worth watching and appreciating, else we will witness accidents and face criticism of public at large.
It is good to promote a corporate image of CDSCO head quarters and its chief as corporate head. Talks are on for e-governance leading to e-submission of applications, online licensing, paperless office of CDSCO HQ, video-conferencing with the officers and later with member of public, and so on. These utterances and promises are again a tightrope walk more so when electronic connectivity of intra-office and with that of other drug regulatory agencies of the states is yet to begin. If done at a fast pace, it will be good for India Inc.
Few of the initiatives in direction of international image building are mentioned here. Readers may feel that only chinks in image are highlighted, for any positive thinking mind unless shortcomings are spelt out, these will never come for notice of the person concerned and improvement may not be thought of. Critical analysis is good for any performing organisation.
#9679 Medical Devices and related legislation:
Though it has initiated licensing, the legislation for manufacture and testing of devices is yet to bear clarity. Proper guidelines for manufacture and testing of "sterile" and "non-sterile" medical devices are necessary for a tighter control. In our country, unless total shift takes place, guidelines should assume shape of rules. Some progress took place in this direction, which now seem to be stunted as the team which was progressing well in the direction has been disintegrated and people shifted to other jobs. Currently no suitable person with consistent approach seem to be there to strengthen hands of DRA chief for moving at a fast pace for a good regulation of medical devices. A consistency in approach is more important as the field is completely diverse from routine drugs & pharmaceuticals. Device items are made up of metals, plastics, ceramics, rubber, combination of two or more such materials and several other materials. These are regulated entirely differently all over the world. Current requirements for manufacture of medical devices are unclear for sterile devices. It is still debating if manufacture of non-sterile devices or critical components of devices is also to be regulated. A good amount of change in mindset is needed for making a tighter and workable legislation in consultation with DRA in various states. Unless proper legislation is in place, it may not be possible for Indian DRA to conduct inspection of the sites within or outside the country, supplying these devices for ailing patients.
#9679 Registration of firms for imports:
Though DRA has been conducting this job for a number of years now, it still has to set a procedure for inspecting manufacturing sites which are successfully registered for supply of APIs and formulations in the country. Our faith in dossiers submitted by the companies is full, we tend to accept the information and data submitted. Our DRA is not in close contact with DRAs of exporting countries and there seems to be no dialogue. A mechanism is to be developed for gathering information from exporting country's DRAs in case there is change in site of manufacture of API or formulation or medical device or who are traders or any other relevant information for better regulation.
Initially it may have been thought that cosmetics and drugs both affect human body equally and that may have been the reason that our legislation was named as Drugs & Cosmetics Rules. Now cosmetics are permitted to be imported, however, there is no procedure to register the products in the country. Efforts are being made in this direction probably for granting import license to such products, a quicker action in the direction will impart confidence in buyers for picking up genuine and not counterfeit product from the market.
Another field which require attention is nutritional products popularly known as dietary supplement or feed supplement. Our DRA or if the Indian Food Authorities (who now sits in the same building) can come together to recognise this category for registration with support of DMF, the requirement of details in DMF may not be as elaborate as these are asked for drugs. (DMF with minimum essential details may be accepted for country). This action will promote an ethical business and weed out trash from this market.
#9679 Exports:
Whole exercise of recent initiatives at DRA is with a view that India is exporting good amount of drugs and pharmaceuticals to most of developing and developed countries in the world. The oft repeated claim in many forums for past 3-4 years that "India is having maximum number of US FDA approved plants outsides USA" may lose its weightage if exports of good quality products are treated on par with not so good quality products. This is mainly because our drug rules do not have clear provisions for this activity. Separate provisions are therefore required for monitoring exports and keeping the esteem of Indian products.
#9679 Modernisation of laboratories CDL and CDTLs
It is not known if our national statutory laboratories can boast of being on par with any good laboratories across the globe in their setup and facilities even though our analysts are very competent and can be considered comparable with any of the good laboratories around the world. It is frustrating to know that an analysis and receiving report on any sample may take few weeks to few months by laboratories under the control of DRA of India. What control mechanism can work if the reports on samples are received late? Our laboratories definitely need an image boost-up. This can happen if our laboratories are equipped with world-class instruments, capabilities are there for analysing NCEs and newer FDCs, they are able to comment on the methods of analysis submitted to them. Augmentation is needed not only in chemical analysis field, but also in pharmacology and microbiology laboratory facilities available with them.
#9679 Zonal office infrastructure and port offices
The zonal offices of CDSCO are supposedly headed by a Dy. Drugs Controller. However, for past about 12-14 years these offices did not have any full time officer. The officers posing to be in seat were either in-charge or were looking after these posts in addition to their assigned positions. Without proper officer for such long number of years, it was in fact no-one's job to set-up proper zonal office. Most of these offices function in small premises, with hardly any space available for orderly upkeep of the area and maintenance. Computers provided in these offices are principally used for typewriting purposes. Situation is no different in port offices.
Most of the important zonal offices in the west zone are lacking in manpower. The officer comes from Ahmedabad to deal with the matters and his days of attending offices. Zonal officers have been thoroughly trained to expect very high degree of GMPs from manufacturing firms, more so when WHO texts are referred. They conveniently forget Good Regulatory Practice prescription of WHO when it is expected from them. Changing conditions for better work atmosphere and good delivery of work are the need of the hour.
CROs are another important services sector that call for attention for both India Inc and globally. With approximately 10 years of conducting clinical trials in the country, proper legislation for controlling establishments engaged in any kind of contract research could not have been made. Similar is the situation with centres performing BA/ BE studies. Formulation development is another field where trans-national companies are operating. All such centres are only remotely regulated. It is expected that Drugs Controller India will form a visible team of officers under his control and work according to procedure.
(The author is former deputy drugs controller (I) I/c CDSCO)