The pharmaceutical industry in India in recent times has been growing steadily, keeping pace with the rest of the world. This growth is reflected in its clinical research segment, as the country is rapidly becoming a global hub for clinical research, with some of the world leaders setting up their base, either directly or through collaboration.
With its lower cost advantage and world-class standard laboratories and equipment India has successfully attracted foreign players to conduct some of their clinical research activities in the country. Also, its vast number of experienced and qualified professionals has been another attraction for the foreign pharma players to tap emerging clinical research market opportunities in India.
Other important advantages that India offers in the clinical research segment include:
● Patient diversity and heterogeneity
● Familiarity with western medical facilities
● English competency
● Project management competency
● Industry friendly regulatory guidelines and government policies
Clinical research involves clinical trials, to determine the safety and efficacy of new drugs or treatments. These trials are conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
In phase I trial, researchers test a new drug or treatment in a small group of healthy people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
In phase II trials, the studied drug or treatment is given to a selected group of patients (100-300) to see if it is effective and to further evaluate its safety.
In phase III trials, the studied drug or treatment is given to a large group of patients (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
In phase IV trials, post-marketing studies delineate additional information, including the drug's risks, benefits and optimal use.
In clinical research, 'double blind' studies proved more reliable and effective, as they allow for no bias on either side. In a double blind study, both the subject and the person managing or administering the experiment know the critical aspects of it. The nature of the study guards against experimenter bias as well as the placebo effect.
ACG Worldwide
ACG Worldwide has long been involved in the field of research and development (R&D) as a way of understanding and catering to its target clients. As part of its research, Associated Capsules Pvt Ltd., a member of ACG Worldwide, has developed Clinicaps - two piece hard gelatin capsules that are specially designed to carry out "double blind" studies during the clinical trials.
Clinicaps serve purposes such as:
● To over-encapsulate tablet dosage form
● To over-encapsulate capsule dosage form
● To mask the placebo in appropriate form
Clinicaps features wide diameter, which helps to contain large-diameter or uniquely shaped tablets that eliminate need to split or grind tablets. Another character of Clinicaps is its shorter length that enhances ease of swallowing. After closure (locking), the elongated cap closes tightly on the body keeping only the dome of the body visible thus making it difficult to open, once locked
Clinicaps, presently at the introductory stage, is available in both white and Swedish orange colours. The colorants used are Ti O1 (white) and Ti O2 with iron oxide (Swedish orange), which are globally accepted and approved. It is available in three sizes - AA, A & B and in packing of 5000 capsules.
Clinicaps are made for ease of use and can be filled in most automatic, semi-automatic or manual capsule filling machines. Over-encapsulation systems from Pam Pharmaceuticals & Allied Machinery Co Pvt Ltd, a member of ACG Worldwide, are available to meet all requirements of capsule filling.
(The author is manager, business development, with Associated Capsules Pvt. Ltd. He can be contacted at viren.doke@acg-world.com)