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12. OP-1 and OP-2 in written version submitted that complainant was an existing client of OP-1 and had contacted OP-2 who is the Deputy General Manager, Cellular Therapy Division of OP-1 for enquiring about PRP procedure. Complainant was thereupon informed about the details of PRP procedure for hair growth and explained that the process does not guarantee the same effect in all persons, in the same manner and no assurance of hair re-growth was ever made at any point of time. It was clarified that role of OP-1 is only limited to supply of kits to the registered medical practitioners/doctors based on their request and the name of the doctor who practice in this field had been referred. OP-2 further communicated that in case the complainant is satisfied on his own free will and consent, he can be introduced to the concerned practitioner who conducts the PRP procedure. Complainant was also explained that PRP is concentrated form of autologous platelets and not related to stem therapy. It is further the case of OP-1 & 2 that after the complainant expressed his consent, OP-2 conveyed the cost details to him and also referred name of OP-3 for conducting the PRP procedure. Thereafter, since the complainant expressed dissatisfaction regarding the conduct of procedure in the first session by Dr., Madhuri Aggarwal (OP-3), he was suggested name of Dr. Satish Kishoranadn Arolkar (OP-4) who is a reputed Plastic Surgeon, for conduct of second session. Further, on being conveyed by the complainant that he was satisfied with the second session conducted on 29.07.2013, the third session for PRP was conducted by OP-4 on 26.08.2013. However, after the third session of PRP procedure complainant informed OP-2 that the procedure was not showing any results which was explained to him by OP-2 and the matter was also discussed with OP-4 who advised that complainant should undertake another session so that they could advice for future course of action. Complainant decided to refrain from the fourth session and continued with his complaints followed by filing of complaint.

26. The issue for consideration is whether there has been unfair medical trade practice or deficiency in service on the part of OPs in treating the complainant.

27. Admittedly, the complainant had approached OP-1 in connection with preserving the Umbilical Cord of his wife and daughter and during the aforesaid visits had enquired about the PRP procedure to be undertaken for the purpose of hair growth. Further, he came in touch with OP-2 who was working as an Executive with OP-1. OP-2 apprised complainant of the PRP procedure along with information contained in a printed booklet in this regard circulated by OP-1. Also, information placed on website by OP-1 was brought to notice of complainant. The specific stand taken by OP-1 and 2 is that they merely supply PRP kits in the course of their business to qualified Dermatologists, Plastic Surgeons and Hospitals, which does not require any approvals under the Drugs and Cosmetics Act, 1940. Further, OP-1 duly possessed licence for the purpose of supply/sale of PRP kits.

29. In order to appreciate the contentions raised on behalf of the parties, at the outset, it may be noticed that „PRP therapy‟ is employed for the purpose of hair re-growth and is distinct from Stem Cell Therapy in strict sense, which has been interchangeably and purposely used by the complainant. PRP (Platelet Rich Plasma) therapy for purpose of hair re-growth involves injecting of patient‟s own concentrated blood plasma into the scalp to accelerate healing for the purpose of graft survival and stimulates the dormant follicles. The same is usually carried in 3 to 5 sessions spread over 4-6 weeks. In order to create „Platelet Rich Plasma‟, the blood sample from the patient is placed in a centrifuge device that rapidly spins the sample, separating out the other components of blood from the plasma and concentrates them within the plasma. The blood is processed from the patient‟s body and is not stored or sold, as in the case of blood donations in camps or hospitals. The Platelet Rich Plasma from the patient‟s blood sample is thereafter injected into the target area on scalp for stimulating the hair re-growth process. The said procedure is globally accepted for treating the male pattern baldness, both in preventing the hair loss and promoting the new hair growth. The quantity of blood which is drawn for the aforesaid purpose by the clinician, depends upon the system used and is normally protocol specific to the system. It is also well established that all patients do not uniformly benefit from the hair growth factor treatments like PRP and some patients may experience no benefit. However, the same does not reflect on the competency of the medical practitioner in undertaking the PRP procedure or the efficacy of treatment. It is also well established that there is less risk of infection during procedure and local and temporary pain is not ruled out. At times, requisite medication/ointment may be applied prior to injecting the plasma on the scalp for reducing the pain or numbing the area. No adverse inference can be drawn in the conduct of the procedure as alleged by the complainant merely because an ointment was applied by Dr. Madhuri Agarwal (OP-3), while the application of ointment was not followed by Dr. Satish Kishoranadn Arolkar (OP-4).

30. The distinction between „Platelet Rich Plasma (PRP)‟ and „Stem Cell Therapy‟ in the context of hair re-growth is also pertinent to be noticed though both are regenerative processes using the patient‟s own tissues to promote healing. Primarily, PRP uses concentrated blood plasma to accelerate the repair, whereas the Stem Cell Therapy employs stem cell harvested from fat or bone marrow to create new tissues. PRP merely releases the growth factors to speed up healing and activates the body‟s existing repair mechanism. On the other hand, Stem Cell Therapy is generally reserved for severe degenerated conditions for replacing damaged tissue. The difference between the two treatments needs to be kept in perspective since the impugned Order and the complaint uses the term „PRP‟ and „Stem Cell Surgery‟, for the same process interchangeably, without appreciating the substantial difference between the two therapies. The aforesaid difference is also important from the perspective of approvals required to be obtained from FDA, DCGI and compliance under the Drugs and Cosmetics Act, 1940 with Rules framed thereunder.